ACTIV-2: A Study for Outpatients With COVID-19
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
2 other identifiers
interventional
4,044
9 countries
252
Brief Summary
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
Typical duration for phase_2
252 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedAugust 2, 2024
August 1, 2024
1.6 years
August 17, 2020
April 7, 2023
August 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
COVID-19 Symptom Duration (Phase 2)
Bamlanivimab arms: Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days. No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition. Non-Bamlanivimab arms: 13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent. No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Up to Day 28
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml). SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions.
Day 3
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Day 7
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms: Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml). Non-Bamlanivimab Agent arms: Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Day 14
Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death
Thru Day 28
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. An event is defined as first occurrence of hospitalization/death (i.e. if subject has multiple hospitalizations, only the first hospitalization is counted as an event). Therefore, an event can only occur once for a subject. Results are presented as number of events.
Thru Day 28
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables. * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death
Thru Day 28
Secondary Outcomes (18)
COVID-19 Symptom Duration (Phase 3)
Thru Day 28
Quantification of SARS-CoV-2 RNA (Phase 3)
Day 3
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
Thru Day 28
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
Thru Day 28
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
Thru Day 14
- +13 more secondary outcomes
Study Arms (25)
Bamlanivimab 7000 mg (Phase 2)
EXPERIMENTALAdministered by IV infusion.
Bamlanivimab 7000mg Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IV infusion
Bamlanivimab 700mg (Phase 2)
EXPERIMENTALAdministered by IV infusion
Bamlanivimab 700mg Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IV infusion
Bamlanivimab 700mg (Phase 3)
EXPERIMENTALAdministered by IV infusion
BRII-196+BRII-198 (Pooled Phase 2/3)
EXPERIMENTALAdministered by IV infusion
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
PLACEBO COMPARATORAdministered by IV infusion
AZD7442 (IV) (Phase 2)
EXPERIMENTALAdministered by IV infusion
AZD7442 (IV) Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
AZD7442 (IM) (Phase 2)
EXPERIMENTALAdministered by IM injection
AZD7442 (IM) Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
SNG001 (Phase 2)
EXPERIMENTALAdministered by inhalation
SNG001 Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Camostat (Phase 2)
EXPERIMENTALAdministered as oral tablets
Camostat Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
SAB-185 (low dose) (Phase 2)
EXPERIMENTALAdministered by IV infusion
SAB-185 (low dose) Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.
SAB-185 (low dose) (Phase 3) Non-OMICRON population
EXPERIMENTALAdministered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: * Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Casirivimab and Imdevimab (Phase 3) Non-OMICRON population
ACTIVE COMPARATORAdministered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: * Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
SAB-185 (high dose) (Phase 2)
EXPERIMENTALAdministered by IV infusion
SAB-185 (high dose) Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.
BMS 986414+BMS 986413 (Phase 2)
EXPERIMENTALAdministered as subcutaneous (SC) injections
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
PLACEBO COMPARATORAdministered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
SAB-185 (low dose) (Phase 3) OMICRON population
EXPERIMENTALAdministered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: * Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Casirivimab and Imdevimab (Phase 3) OMICRON population
ACTIVE COMPARATORAdministered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: * Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. * For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Interventions
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory.
- Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- +30 more criteria
You may not qualify if:
- History of or current hospitalization for COVID-19.
- For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected \> 240 hours prior to study entry.
- Current need for hospitalization or immediate medical attention.
- Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study.
- Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
- Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines).
- Known allergy/sensitivity or hypersensitivity to study drug or placebo.
- Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
- Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- In phase II, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 \[IM\]).
- Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413).
- History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 \[IM\]).
- Use of or need for chronic supplemental oxygen (SNG001).
- Known severe liver disease prior to enrollment (defined as ALT or AST \> 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Eli Lilly and Companycollaborator
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infectionscollaborator
- Brii Biosciences Limitedcollaborator
- AstraZenecacollaborator
- Sagent Pharmaceuticalscollaborator
- Synairgen Research Ltd.collaborator
- Bristol-Myers Squibbcollaborator
- SAb Biotherapeutics, Inc.collaborator
Study Sites (252)
Pinnacle Research Group (Site 1082), 321 E. 10th Street
Anniston, Alabama, 36207-5707, United States
North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
Athens, Alabama, 35611-2456, United States
University of Alabama at Birmingham (Site 1005), 908 20th Street South
Birmingham, Alabama, 35294, United States
Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
Cullman, Alabama, 35055-1921, United States
Jasper Summit Research, LLC. (Site 1056), 1280 Summit
Jasper, Alabama, 35501-0102, United States
Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
Phoenix, Arizona, 85051, United States
University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
Tucson, Arizona, 85724-0001, United States
Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
Anaheim, California, 92804-3729, United States
Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
Bakersfield, California, 93301-1661, United States
Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
Canyon Country, California, 91351-4138, United States
St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
Fullerton, California, 92835-3820, United States
University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
La Jolla, California, 92037, United States
Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
La Mesa, California, 91942-7001, United States
Atella Clinical Research (Site 1111), 5451 La Palma Avenue
La Palma, California, 90623, United States
Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
Loma Linda, California, 92354, United States
University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
Los Angeles, California, 90033-1021, United States
UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
Los Angeles, California, 90035, United States
Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
Los Angeles, California, 90094-2994, United States
VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
Mather, California, 95655-4200, United States
Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
Modesto, California, 95350-5365, United States
Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
Newport Beach, California, 92663-4126, United States
Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
Northridge, California, 91325-4138, United States
University of California Irvine (Site 1083), 843 Health Sciences Road
Orange, California, 92868, United States
FOMAT Medical Research (Site 1136), 300 South A Street
Oxnard, California, 93030, United States
Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
Rancho Mirage, California, 92270-3221, United States
Paradigm Research (Site 1150), 3652 Eureka Way
Redding, California, 96001-0172, United States
Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
Riverside, California, 92506-2658, United States
University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
Sacramento, California, 95817-2201, United States
Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
San Bernardino, California, 92404, United States
University of California San Diego (Site 1002), 220 Dickinson Street
San Diego, California, 92103, United States
Zion Medical Center (Site 1063), 4647 Zion Avenue
San Diego, California, 92120, United States
VA San Diego Health System (Stie 1127), 3350 La Jolla
San Diego, California, 92161-0002, United States
University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
San Francisco, California, 94110, United States
San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
San Francisco, California, 94127-2606, United States
Stanford University (Site 1213), 1201 Welch Road
Stanford, California, 94305-5102, United States
Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
Thousand Oaks, California, 91360-3994, United States
Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
Thousand Oaks, California, 91360-8005, United States
Harbor UCLA (Site 1022), 1124 West Carson Street
Torrance, California, 90502, United States
Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
Westminster, California, 92683-4454, United States
University of Colorado (Site 1007), 12401 East 17th Avenue
Aurora, Colorado, 80045, United States
UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
Storrs, Connecticut, 06269-1248, United States
Whitman-Walker Health (Site 1027), 1337 R Street NW.
Washington D.C., District of Columbia, 20009, United States
Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
Boynton Beach, Florida, 33435-5610, United States
Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
Bradenton, Florida, 34205-1704, United States
Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
Bradenton, Florida, 34208-1004, United States
Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
Daytona Beach, Florida, 32117-5157, United States
Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
DeLand, Florida, 32720-0920, United States
Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
Doral, Florida, 33166-6508, United States
Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
Doral, Florida, 33166-6658, United States
EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
Fort Lauderdale, Florida, 33308, United States
Holy Cross Health (Site 1072), 4725 North Federal Highway
Fort Lauderdale, Florida, 33308, United States
North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
Gainesville, Florida, 32608-1135, United States
University of Florida (Site 1047), 1600 SW. Archer Rd.
Gainesville, Florida, 32610-3003, United States
NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
Gulf Breeze, Florida, 32561, United States
Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
Hialeah, Florida, 33012-4174, United States
AGA Clinical Trials (Site 1026), 900 West 49th Street
Hialeah, Florida, 33012, United States
Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
Hialeah, Florida, 33016-1811, United States
New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
Hialeah, Florida, 33016-1895, United States
Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
Hialeah, Florida, 33016-6890, United States
Innovative Health Medical Center (Site 1222), 6750 Taft Street
Hollywood, Florida, 33024, United States
University of Florida Jacksonville (Site 1039), 655 West 8th Street
Jacksonville, Florida, 32209, United States
Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
Jacksonville, Florida, 32224-1865, United States
Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
Miami, Florida, 33125, United States
Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
Miami, Florida, 33135-2906, United States
Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
Miami, Florida, 33135-2968, United States
University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
Miami, Florida, 33136, United States
Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
Miami, Florida, 33155-2164, United States
D&H National Research Centers (Site 1205), 8485 Bird Road
Miami, Florida, 33155-3244, United States
Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
Miami, Florida, 33155-4630, United States
Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
Miami, Florida, 33155, United States
Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
Miami, Florida, 33173-4648, United States
RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
Miami, Florida, 33174-1746, United States
Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
Miami, Florida, 33175-3437, United States
Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
Miami, Florida, 33176-2230, United States
QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
Miami Beach, Florida, 33140-3627, United States
Lakes Research (Site 1037), 5801 NW 151 Street
Miami Lakes, Florida, 33014, United States
Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
Miami Lakes, Florida, 33014, United States
Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
Miami Shores, Florida, 33138, United States
Bravo Health Care Center (Site 1221), 1440 79 Street
North Bay Village, Florida, 33141, United States
Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
Orlando, Florida, 32803, United States
Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
Orlando, Florida, 32819, United States
IMIC, Inc. (Site 1141), 18320 Franjo Rd
Palmetto Bay, Florida, 33157-5503, United States
Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
Pembroke Pines, Florida, 33026-3240, United States
Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
Sarasota, Florida, 34239-3132, United States
Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
Sebring, Florida, 33870-1216, United States
DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
Tamarac, Florida, 33321-2954, United States
ETNA Medical Center (Site 1225), 7401 N. University Drive
Tamarac, Florida, 33342, United States
Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
Tampa, Florida, 33609-2230, United States
Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
Tampa, Florida, 33610-1469, United States
Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
Vero Beach, Florida, 32960-4889, United States
AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
Vero Beach, Florida, 32960, United States
Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
West Palm Beach, Florida, 33407-3100, United States
The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
Atlanta, Georgia, 30308, United States
Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
Atlanta, Georgia, 30318-2512, United States
Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
Atlanta, Georgia, 30328, United States
Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
Buford, Georgia, 30518-8802, United States
IACT Health (Site 1035), 800 Talbotton Road
Columbus, Georgia, 31904, United States
Clintheory (Site 1254), 4300 Pleasant Hill Road
Duluth, Georgia, 30096, United States
One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
Norcross, Georgia, 30093, United States
Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
Snellville, Georgia, 30078-5779, United States
John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
Honolulu, Hawaii, 96813, United States
Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
Idaho Falls, Idaho, 83404-7554, United States
Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
Burr Ridge, Illinois, 60527-0872, United States
Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
Chicago, Illinois, 60607-4911, United States
Northwestern University (Site 1025), 645 North Michigan Ave
Chicago, Illinois, 60611, United States
Rush University Medical Center (Site 1017), 600 Paulina St.
Chicago, Illinois, 60612, United States
University of Illinois at Chicago (Site 1147), 835 South Wood Street
Chicago, Illinois, 60612, United States
University of Chicago (Site 1064), 5841 S. Maryland Ave.
Chicago, Illinois, 60637-1443, United States
Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
Chicago, Illinois, 60640-2831, United States
Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
Brownsburg, Indiana, 46112-2415, United States
Roudebush VA Medical Center (Site 1217), 550 University Blvd
Indianapolis, Indiana, 46202-5149, United States
University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
Kansas City, Kansas, 66160, United States
MedPharmics (Site 1065), 3800 Houma Blvd.
Metairie, Louisiana, 70006, United States
Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
Monroe, Louisiana, 71201, United States
New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
New Orleans, Louisiana, 70112-2703, United States
Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
New Orleans, Louisiana, 70112-3018, United States
Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
New Orleans, Louisiana, 70121, United States
Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
Baltimore, Maryland, 21201-1524, United States
Johns Hopkins University (Site 1006), 1830 East Monument Street
Baltimore, Maryland, 21205, United States
Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
Silver Spring, Maryland, 20910-7500, United States
Massachusetts General Hospital (Site 1016), 55 Fruit Street
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
Boston, Massachusetts, 02215, United States
University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
Worcester, Massachusetts, 01655-0002, United States
Vida Clinical Studies (Site 1244), 3815 Pelham Street
Dearborn, Michigan, 48124, United States
Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
Farmington Hills, Michigan, 48334-1566, United States
Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
Sterling Heights, Michigan, 48312, United States
Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
Gulfport, Mississippi, 39501, United States
MedPharmics, LLC. (Site 1032), 15190 Community Rd.
Gulfport, Mississippi, 39503, United States
University of Missouri Health Care System (Site 1224), 1 Hospital Drive
Columbia, Missouri, 65212-1000, United States
Hannibal Clinic (Site 1129), 100 Medical Drive
Hannibal, Missouri, 63401, United States
Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
St Louis, Missouri, 63110, United States
Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
Bozeman, Montana, 59715-6911, United States
Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
Butte, Montana, 59701-1652, United States
Quality Clinical Research (Site 1112), 10040 Regency Circle
Omaha, Nebraska, 68114, United States
Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
Las Vegas, Nevada, 89113-2215, United States
AXCES Research Group (Site 1152), 531 Harkle Road
Santa Fe, New Mexico, 87505, United States
Maimonides Medical Center (Site 1138), 4802 10th Avenue
Brooklyn, New York, 11219-2916, United States
University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
Buffalo, New York, 14203, United States
Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
Flushing, New York, 11355-2205, United States
Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
Jamaica, New York, 11418-2832, United States
Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604
New York, New York, 10032, United States
Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
New York, New York, 10065, United States
Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
Potsdam, New York, 13676-1786, United States
University of Rochester (Site 1010), 601 Elmwood Ave
Rochester, New York, 14642, United States
SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
Stony Brook, New York, 11794, United States
Bronx Prevention Research Center (Site 1108), 390 East 158th Street
The Bronx, New York, 10451, United States
Lincoln Hospital (Site 1092), 249 East 149th Street
The Bronx, New York, 10451, United States
Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
The Bronx, New York, 10459-2417, United States
Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
The Bronx, New York, 10461, United States
James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
The Bronx, New York, 10468, United States
University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
Chapel Hill, North Carolina, 27514, United States
Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
Charlotte, North Carolina, 38273-5716, United States
Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
Denver, North Carolina, 28037, United States
Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
Durham, North Carolina, 27710, United States
Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
Morehead City, North Carolina, 28557, United States
Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
Winston-Salem, North Carolina, 27157-0001, United States
Sanford Health (Site 1084), 801 Broadway N.
Fargo, North Dakota, 58102-3641, United States
The Christ Hospital (Site 1119), 2123 Auburn Avenue
Cincinnati, Ohio, 45219, United States
Case Western Reserve University (Site 1033), 2061 Cornell Road
Cleveland, Ohio, 44106-5083, United States
MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
Cleveland, Ohio, 44109-1900, United States
Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
Columbus, Ohio, 43210, United States
Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
Ohio City, Ohio, 45219, United States
STAT Research (Site 1107), 66 Remick Blvd.
Springboro, Ohio, 45066-9168, United States
Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
Tulsa, Oklahoma, 74104, United States
Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
Portland, Oregon, 97213-2933, United States
Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
Portland, Oregon, 97227-1110, United States
Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
Portland, Oregon, 97239-2964, United States
Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
Portland, Oregon, 97239-3015, United States
Doylestown Hospital (Site 1122), 595 W. State Street
Doylestown, Pennsylvania, 18901-2554, United States
University of Pennsylvania (Site 1031), 3400 Spruce Street
Philadelphia, Pennsylvania, 19104, United States
The University of Pittsburgh (Site 1018), 3471 5th Ave.
Pittsburgh, Pennsylvania, 15213-3215, United States
Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
Pittsburgh, Pennsylvania, 15240, United States
The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
Providence, Rhode Island, 02906, United States
Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
Columbia, South Carolina, 29204-2410, United States
Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
West Columbia, South Carolina, 29169, United States
American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
Rapid City, South Dakota, 57701, United States
Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
Sioux Falls, South Dakota, 57105-0401, United States
Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
Franklin, Tennessee, 37067, United States
Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
Nashville, Tennessee, 37204-4718, United States
Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
Bellaire, Texas, 77401-4516, United States
South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
Boerne, Texas, 78006, United States
PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
Brownsville, Texas, 78520-7256, United States
Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
Dallas, Texas, 75208, United States
UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
Dallas, Texas, 75235, United States
Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
Edinburg, Texas, 78539, United States
Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
Galveston, Texas, 77555-0001, United States
Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
Houston, Texas, 77004-6938, United States
Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
Houston, Texas, 77026-1967, United States
University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
Houston, Texas, 77030-1501, United States
Houston Methodist Hospital (Site 1123), 6565 Fannin Street
Houston, Texas, 77030-2703, United States
Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
Houston, Texas, 77074-1603, United States
Fairway Medical Clinic (Site 1156), 4910 Telephone Road
Houston, Texas, 77087, United States
Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
Humble, Texas, 77338, United States
SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
Mesquite, Texas, 75149-2438, United States
Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
Red Oak, Texas, 75154, United States
San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
San Antonio, Texas, 78234-4504, United States
Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
Falls Church, Virginia, 22042-3307, United States
Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
Richmond, Virginia, 23226-3787, United States
EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
Kirkland, Washington, 98034-3013, United States
University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
Seattle, Washington, 98104, United States
Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
Spokane, Washington, 99204-2312, United States
Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
Huntington, West Virginia, 25704, United States
West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
Morgantown, West Virginia, 26506-1200, United States
Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
Milwaukee, Wisconsin, 53219, United States
Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
Milwaukee, Wisconsin, 53226, United States
Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200
Wauwatosa, Wisconsin, 53226-1304, United States
Instituto Médico Platense (Site 3011), Avenida 51 335
La Plata, Buenos Aires, B1900AVG, Argentina
Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
Buenos Aires, Buenos Aires F.D., C1180AAX, Argentina
Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
Río Cuarto, Córdoba Province, 5800, Argentina
Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
Rosario, Santa Fe Province, S2013DTC, Argentina
Clínica Adventista Belgrano (Site 3007), Estomba 1710
Buenos Aires, C1430EGF, Argentina
Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
Mar del Plata, B7602DCK, Argentina
Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
Pilar, B1629ODT, Argentina
L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
Brasília, Federal District, 70200-730, Brazil
Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
Belo Horizonte, Minas Gerais, 30130-100, Brazil
SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
Porto Alegre, Rio Grande do Sul, 91850-200, Brazil
Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
Blumenau, Santa Catarina, 89030-101, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
Ribeirão Preto, São Paulo, 14048-900, Brazil
Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
Rio de Janeiro, 21040-360, Brazil
Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
São Paulo, 13059-900, Brazil
Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.
Kelowna, British Columbia, V1Y 4N7, Canada
Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
Guatemala City, 01011, Guatemala
CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
Torreón, Coahuila, 27000, Mexico
Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
Guadalajara, Jalisco, 44100, Mexico
Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
Guadalajara, Jalisco, 44160, Mexico
Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
Oaxaca, Mexico City, 68000, Mexico
Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
Culiacán, Sinaloa, 80020, Mexico
Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
Culiacán, Sinaloa, 80030, Mexico
Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
Mérida, Yucatán, 97000, Mexico
Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
Mérida, Yucatán, 97070, Mexico
De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
Cavite City, Cavite, 4114, Philippines
Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
Makati City, National Capital Region, 1229, Philippines
Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
Muntinlupa, National Capital Region, 1780, Philippines
Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
San Juan, 00935, Puerto Rico
Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
Kempton Park, Ekurhuleni, Gauteng, 1619, South Africa
Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
Benoni, Gauteng, 1501, South Africa
The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
Johannesburg, Gauteng, 1632, South Africa
Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
Johannesburg, Gauteng, 1724, South Africa
Soweto ACTG CRS (Site 9203), Chris Hani Road
Johannesburg, Gauteng, 1862, South Africa
Helen Joseph Hospital (Site 9201), Perth Road
Johannesburg, Gauteng, 9092, South Africa
Setshaba Research Centre (Site 9205), 2088 Block H
Pretoria, Gauteng, 0152, South Africa
Into Research (Site 9210), Totius Street
Pretoria, Gauteng, 181, South Africa
Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
Durban, KwaZulu-Natal, 4052, South Africa
Welkom Clinical Trial Centre (Site 9211), 189 Power Road
Welkom, Matjhabeng, Free State, 9459, South Africa
The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
Klerksdorp, North West, 2571, South Africa
The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
Rustenburg, North West, 300, South Africa
TASK Eden (Site 9218), G, 4 Victoria St.
George, 6530, South Africa
CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
Johannesburg, 1619, South Africa
Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
Mpumalanga, 1055, South Africa
Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
Pretoria, 2000, South Africa
Related Publications (44)
Currier JS, Moser C, Eron JJ, Chew KW, Smith DM, Javan AC, Wohl DA, Daar ES, Hughes MD; ACTIV-2/A5401 Study Team. ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients. J Infect Dis. 2023 Aug 31;228(Suppl 2):S77-S82. doi: 10.1093/infdis/jiad246.
PMID: 37650231BACKGROUNDChew KW, Moser C, Yeh E, Wohl DA, Daar ES, Ritz J, Javan AC, Eron JJ, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S83-S91. doi: 10.1093/infdis/jiad300.
PMID: 37650237BACKGROUNDMoser CB, Chew KW, Ritz J, Newell M, Javan AC, Eron JJ, Daar ES, Wohl DA, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S92-S100. doi: 10.1093/infdis/jiad209.
PMID: 37650234BACKGROUNDMoser CB, Chew KW, Giganti MJ, Li JZ, Aga E, Ritz J, Greninger AL, Javan AC, Bender Ignacio R, Daar ES, Wohl DA, Currier JS, Eron JJ, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials. J Infect Dis. 2023 Aug 31;228(Suppl 2):S101-S110. doi: 10.1093/infdis/jiad285.
PMID: 37650235BACKGROUNDBender Ignacio RA, Wohl DA, Arends R, Pilla Reddy V, Mu Y, Javan AC, Hughes MD, Eron JJ, Currier JS, Smith D, Chew KW, Gibbs M, Fletcher CV. Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS-CoV-2 Infection. Clin Pharmacol Ther. 2022 Dec;112(6):1207-1213. doi: 10.1002/cpt.2706. Epub 2022 Jul 26.
PMID: 35797235RESULTBoucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA 2nd, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM; POSITIVES study team; Li JZ, Barczak AK; ACTIV-2/A5401 Study Team. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 Jul 19;3(7):100678. doi: 10.1016/j.xcrm.2022.100678. Epub 2022 Jun 20.
PMID: 35793677RESULTChew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs RW, Ritz J, Giganti M, Javan AC, Li Y, Choudhary MC, Deo R, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS; ACTIV-2/A5401 Study Team; Hughes MD, Smith DM. Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19. Nat Commun. 2022 Aug 22;13(1):4931. doi: 10.1038/s41467-022-32551-2.
PMID: 35995785RESULTLi Y, Harrison LJ, Chew KW, Currier JS, Wohl DA, Daar ES, Evering TH, Wu R, Giganti M, Ritz J, Javan AC, Coombs RW, Moser C, Hughes MD, Eron JJ, Smith DM, Li JZ. Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019. Clin Infect Dis. 2023 Feb 18;76(4):734-737. doi: 10.1093/cid/ciac818.
PMID: 36210483RESULTSmith DM, Li JZ, Moser C, Yeh E, Currier JS, Chew KW, Hughes MD; ACTIV-2/A5401 Study Team. Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19. JAMA Netw Open. 2022 Oct 3;5(10):e2238867. doi: 10.1001/jamanetworkopen.2022.38867.
PMID: 36301549RESULTChoudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 Nov;7(11):1906-1917. doi: 10.1038/s41564-022-01254-1. Epub 2022 Oct 26.
PMID: 36289399RESULTMoser C, Li JZ, Eron JJ, Aga E, Daar ES, Wohl DA, Coombs RW, Javan AC, Bender Ignacio RA, Jagannathan P, Ritz J, Sieg SF, Parikh UM, Hughes MD, Currier JS, Smith DM, Chew KW; ACTIV-2/A5401 Study Team. Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19. Open Forum Infect Dis. 2022 Nov 11;9(11):ofac618. doi: 10.1093/ofid/ofac618. eCollection 2022 Nov.
PMID: 36467293RESULTRamirez SI, Grifoni A, Weiskopf D, Parikh UM, Heaps A, Faraji F, Sieg SF, Ritz J, Moser C, Eron JJ, Currier JS, Klekotka P, Sette A, Wohl DA, Daar ES, Hughes MD, Chew KW, Smith DM, Crotty S; Accelerating COVID-19 Therapeutic Interventions and Vaccines-2/A5401 (ACTIV-2/A5401) Study Team. Bamlanivimab therapy for acute COVID-19 does not blunt SARS-CoV-2-specific memory T cell responses. JCI Insight. 2022 Dec 22;7(24):e163471. doi: 10.1172/jci.insight.163471.
PMID: 36378539RESULTJilg N, Chew KW, Giganti MJ, Daar ES, Wohl DA, Javan AC, Kantor A, Moser C, Coombs RW, Neytman G, Hoover K, Jana A, Hart PA, Greninger AL, Szurgot B, Eron JJ, Currier JS, Hughes MD, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial. Clin Infect Dis. 2023 Oct 5;77(7):941-949. doi: 10.1093/cid/ciad342.
PMID: 37279602RESULTTaiwo BO, Chew KW, Moser C, Wohl DA, Daar ES, Li JZ, Greninger AL, Bausch C, Luke T, Hoover K, Neytman G, Giganti MJ, Olefsky M, Javan AC, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19. J Infect Dis. 2023 Jul 14;228(2):133-142. doi: 10.1093/infdis/jiad013.
PMID: 36661240RESULTEvering TH, Chew KW, Giganti MJ, Moser C, Pinilla M, Wohl DA, Currier JS, Eron JJ, Javan AC, Bender Ignacio R, Margolis D, Zhu Q, Ma J, Zhong L, Yan L, D'Andrea Nores U, Hoover K, Mocherla B, Choudhary MC, Deo R, Ritz J, Fischer WA, Fletcher CV, Li JZ, Hughes MD, Smith D, Daar ES; ACTIV-2/A5401 Study Team. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19. Ann Intern Med. 2023 May;176(5):658-666. doi: 10.7326/M22-3428. Epub 2023 Apr 18.
PMID: 37068272RESULTBender Ignacio RA, Chew KW, Moser C, Currier JS, Eron JJ, Javan AC, Giganti MJ, Aga E, Gibbs M, Tchouakam Kouekam H, Johnsson E, Esser MT, Hoover K, Neytman G, Newell M, Daar ES, Fischer W, Fletcher CV, Li JZ, Greninger AL, Coombs RW, Hughes MD, Smith D, Wohl DA; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-2/A5401 Study Team. Safety and Efficacy of Combined Tixagevimab and Cilgavimab Administered Intramuscularly or Intravenously in Nonhospitalized Patients With COVID-19: 2 Randomized Clinical Trials. JAMA Netw Open. 2023 Apr 3;6(4):e2310039. doi: 10.1001/jamanetworkopen.2023.10039.
PMID: 37099295RESULTDeo R, Choudhary MC, Moser C, Ritz J, Daar ES, Wohl DA, Greninger AL, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW, Li JZ; ACTIV-2/A5401 Study Team. Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection. Ann Intern Med. 2023 Mar;176(3):348-354. doi: 10.7326/M22-2381. Epub 2023 Feb 21.
PMID: 36802755RESULTLi Y, Moser C, Aga E, Currier JS, Wohl DA, Daar ES, Ritz J, Greninger AL, Sieg S, Parikh UM, Coombs RW, Hughes MD, Eron JJ, Smith DM, Chew KW, Li JZ; ACTIV-2/A5401 Study Team. Immune Status and SARS-CoV-2 Viral Dynamics. J Infect Dis. 2023 Aug 31;228(Suppl 2):S111-S116. doi: 10.1093/infdis/jiad200.
PMID: 37650232RESULTGiganti MJ, Chew KW, Eron JJ, Li JZ, Pinilla M, Moser C, Javan AC, Fischer WA, Klekotka P, Margolis D, Wohl DA, Coombs RW, Daar ES, Smith DM, Currier JS, Hughes MD; ACTIV-2/A5401 Study Team. Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19. J Infect Dis. 2023 Aug 31;228(Suppl 2):S117-S125. doi: 10.1093/infdis/jiad287.
PMID: 37650230RESULTEvering TH, Moser CB, Jilg N, Yeh E, Sanusi B, Wohl DA, Daar ES, Li JZ, Klekotka P, Javan AC, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW; ACTIV-2/A5401 Study Team. Long COVID After Bamlanivimab Treatment. J Infect Dis. 2023 Aug 31;228(Suppl 2):S126-S135. doi: 10.1093/infdis/jiad286.
PMID: 37650236RESULTRibeiro RM, Choudhary MC, Deo R, Giganti MJ, Moser C, Ritz J, Greninger AL, Regan J, Flynn JP, Wohl DA, Currier JS, Eron JJ, Hughes MD, Smith DM, Chew KW, Daar ES, Perelson AS, Li JZ; ACTIV-2/A5401 Study Team. Variant-Specific Viral Kinetics in Acute COVID-19. J Infect Dis. 2023 Aug 31;228(Suppl 2):S136-S143. doi: 10.1093/infdis/jiad314.
PMID: 37650233RESULTKara W. Chew, Carlee B. Moser, Eric S. Daar, David A. Wohl, Eunice Yeh, Justin Ritz, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Davey M. Smith, Michael D. Hughes, for the ACTIV-2/A5401 Study Team. SYMPTOM OUTCOME MEASURES FOR OUTPATIENT COVID-19 PHASE 3 TREATMENT TRIALS. Presented at conference, 03/10/2021. 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021, Chicago, IL and/or Virtual, 03/06/2021 - 03/10/2021. (A5401)
RESULTKara W. Chew, Carlee B. Moser, Jonathan Z. Li, Robert W. Coombs, Eric S. Daar, David A. Wohl, Evgenia Aga, Justin Ritz, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, for the ACTIV-2/A5401 Study Team. SARS-CoV-2 RNA LEVELS CORRELATE WITH SYMPTOM DURATION BUT NOT SEVERITY IN OUTPATIENTS. Presented at conference, 03/10/2021. 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021, Chicago, IL and/or Virtual, 03/06/2021 - 03/10/2021. (A5401)
RESULTTeresa H. Evering, Mark J. Giganti, Kara W. Chew, Michael D. Hughes, Carlee B. Moser, David A. Wohl, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, David Margolis, Qing Zhu, Ulises D'Andrea, Keila Hoover, Bharat R. Mocherla, Courtney Fletcher, Jonathan Li, Davey M. Smith, Eric S. Daar. SAFETY AND EFFICACY OF COMBINATION SARS-CoV-2 MONOCLONAL NEUTRALIZING ANTIBODIES (MAB) BRII-196 AND BRII-198 IN NON-HOSPITALIZED COVID-19 PATIENTS. Presented at conference, 09/30/2021. 2021 IDWeek, Virtual, 09/20/2021 - 10/03/2021
RESULTTeresa H. Evering, Busola Sanusi, Nikolaus Jilg, Eunice Yeh, Carlee B. Moser, Justin Ritz, David A. Wohl, Eric S. Daar, Paul Klekotka, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, and Kara W. Chew, on behalf of the ACTIV-2/A5401 Study Team and Investigators. PREVALENCE AND CHARACTERISTICS OF POST-ACUTE SEQUELAE OF SARS¬-CoV¬-2 (PASC) IN NON¬-HOSPITALIZED PERSONS WITH COVID-¬19 ENROLLED IN A CLINICAL TRIAL OF EARLY TREATMENT (ACTIV-2). Presented at conference, 12/06/2021. 2021 International Workshop on Long-term Complications of HIV and SARS-¬CoV-¬2, Virtual, 12/06/2021 - 12/09/2021. (A5401)
RESULTNikolaus Jilg, Kara W. Chew, Mark J. Giganti, Eric S. Daar, David A. Wohl, Arzhang Cyrus Javan, Amy Kantor, Atasi Jana, Philip A. Hart, Joseph J. Eron, Judith S. Currier, Michael Hughes, Davey M. Smith, Jonathan Z. Li. CAMOSTAT IS NOT EFFECTIVE FOR MILD-MODERATE COVID-19 IN A PHASE 2 TRIAL OF ACTIV-2. Accepted by conference - oral presentation, 01/20/2022. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
RESULTBabafemi O. Taiwo, Kara W. Chew, Mark Giganti, David A. Wohl, Eric S. Daar, Maxine Olefsky, Rick Finnegan, Jake Miles, Arzhang Cyrus Javan, Jonathan Li, Judith S. Currier, Joseph J. Eron, Michael D. Hughes, Davey M. Smith. PHASE-2 EVALUATION OF SAB-185, A POLYCLONAL ANTIBODY TREATMENT FOR COVID-19 IN ACTIV-2. Accepted by conference - poster presentation, 01/20/2022. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
RESULTTeresa H. Evering, Busola Sanusi, Nikolaus Jilg, Eunice Yeh, Carlee B. Moser, David A. Wohl, Eric S. Daar, Paul Klekotka, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, Kara W. Chew. POST-ACUTE SEQUELAE OF SARS-¬CoV-¬2 IN NON-¬HOSPITALIZED ACTIV-¬2 TRIAL PARTICIPANTS. Accepted by conference - poster presentation, 12/10/2021. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
RESULTMark J. Giganti, Kara W. Chew, Joseph J. Eron, Jonathan Z. Li, Mauricio Pinilla, Carlee B. Moser, Arzhang Cyrus Javan, William A. Fischer, Paul Klekotka, David Margolis, David A. Wohl, Robert W. Coombs, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Judith S. Currier, for the ACTIV-2/A5401 Study Team. ASSOCIATION BETWEEN ANTERIOR NASAL AND PLASMA SARS-CoV-2 RNA LEVELS AND HOSPITALIZATION OR DEATH FOR NON-HOSPITALIZED ADULTS WITH MILD-TO-MODERATE COVID-19. Accepted by Conference, 06/30/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
RESULTCarlee B. Moser, Jonathan Z. Li, Joseph J. Eron, Evgenia Aga, Eric S. Daar, David A. Wohl, Robert W. Coombs, Arzhang Cyrus Javan, Rachel A Bender Ignacio, Prasanna Jagannathan, Justin Ritz, Scott Sieg, Urvi M. Parikh, Michael D. Hughes, Judith S. Currier, Davey M. Smith, Kara W. Chew. FEMALE SEX AND SARS-CoV-2 SEROSTATUS PREDICT NASOPHARYNGEAL RNA CLEARANCE DURING EARLY COVID-19. Accepted by conference - poster presentation, 09/13/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
RESULTYijia Li, Linda J. Harrison, Kara W. Chew, Joseph J. Eron, Eric S. Daar, David A. Wohl, Ryan Wu, Carlee B. Moser, Justin Ritz, Arzhang Cyrus Javan, Robert W. Coombs, Michael D. Hughes, Judith S. Currier, Davey M. Smith, Jonathan Z. Li. NASAL AND PLASMA SARS-CoV-2 RNA LEVELS PREDICT TIMING OF SYMPTOM RESOLUTION IN THE ACTIV-2 TRIAL OF NON-HOSPITALIZED ADULTS WITH COVID-19. Accepted by conference - oral presentation, 09/12/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
RESULTTeresa H. Evering*, Carlee B. Moser*, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith*, Michael D. Hughes*, Kara W. Chew*, for the ACTIV-2/A5401 Study Team. *Contributed equally. POST-ACUTE COVID OUTCOMES: AMUBARVIMAB+ROMLUSEVIMAB VS PLACEBO IN THE ACTIV-2 TRIAL. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. Submitted for Review, 12/08/2022. (A5401).
RESULTYijia Li, Carlee B. Moser, Evgenia Aga, Judith S. Currier, David A. Wohl, Eric S. Daar, Justin Ritz, Robert W. Coombs, Michael D. Hughes, Joseph J. Eron, Davey M. Smith, Kara W. Chew, Jonathan Z. Li. IMMUNE STATUS AND SARS-COV-2 VIRAL DYNAMICS. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTRinki Deo, Manish C. Choudhary, Carlee B. Moser, Justin Ritz, Eric S. Daar, David A. Wohl, Alexander L. Greninger, Joseph J. Eron, Judith S. Currier, Michael D. Hughes*, Davey M. Smith*, Kara W. Chew*, Jonathan Z. Li*, for the ACTIV-2/A5401 Study Team. *Contributed equally. SYMPTOM AND VIRAL REBOUND IN UNTREATED COVID-19 INFECTION. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTRachel Bender Ignacio*, Kara W. Chew*, Carlee B. Moser, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, Evgenia Aga, Michael Gibbs, Herve Tchouakam Kouekam, Matthew Newell, Eric S. Daar, Jonathan Z. Li, Michael D. Hughes, Davey M. Smith, and David A. Wohl, for the ACTIV-2/A5401 Study Team. TIXAGEVIMAB/CILGAVIMAB IM AND IV IN SYMPTOMATIC COVID-19: A RANDOMIZED CONTROLLED ACTIV-2 TRIAL. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTNikolaus Jilg, Mark J. Giganti, Kara W. Chew, Kathryn Shaw-Saliba, Justin Ritz, Carlee B. Moser, Teresa H. Evering, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, H. Cliff Lane, Robin L. Dewar*, Davey M. Smith*, Jonathan Z. Li*. *Contributed equally. PLASMA ANTIBODY AND N ANTIGEN STATUS PREDICT OUTCOMES IN OUTPATIENTS WITH COVID-19. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTPrasanna Jagannathan*, Kara W. Chew*, Mark J. Giganti, Michael D. Hughes, Mark Main, Phillip Monk, Arzhang Cyrus Javan, Jonathan Z. Li, David A. Wohl, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Upinder Singh*, Davey M. Smith*, William Fischer*. *Contributed equally. SAFETY AND EFFICACY OF INHALED INTERFERON-β1A (SNG001) IN OUTPATIENTS WITH COVID-19. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTManish C. Choudhary, Rinki Deo, Teresa H. Evering, Kara W. Chew, Mark J. Giganti, Carlee B. Moser, Justin Ritz, David A. Wohl, Judith S. Currier, Joseph J. Eron, David Margolis, Yun Ji, Michael D. Hughes, Davey M. Smith, Eric S. Daar, Jonathan Z. Li for the ACTIV-2/A5401 Study Team. CHARACTERIZATION OF SINGLE VERSUS DUAL ACTIVE MONOCLONAL ANTIBODIES AGAINST SARS-CoV-2. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
RESULTJagannathan P, Chew KW, Giganti MJ, Hughes MD, Moser C, Main MJ, Monk PD, Javan AC, Li JZ, Fletcher CV, McCarthy C, Wohl DA, Daar ES, Eron JJ, Currier JS, Singh U, Smith DM, Fischer W; ACTIV-2/A5401 Study Team. Safety and efficacy of inhaled interferon-beta1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial. EClinicalMedicine. 2023 Oct 6;65:102250. doi: 10.1016/j.eclinm.2023.102250. eCollection 2023 Nov.
PMID: 37855026RESULTChew KW, Taiwo BO, Moser C, Daar ES, Wohl DA, Ritz J, Javan AC, Li JZ, Fischer W, Greninger AL, Bausch C, Luke T, Call R, Neytman G, Giganti MJ, Fletcher CV, Hughes MD, Eron JJ, Currier JS, Smith DM; ACTIV-2/A5401 Study Team. Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial. J Infect Dis. 2024 Nov 15;230(5):1177-1186. doi: 10.1093/infdis/jiae369.
PMID: 39028902DERIVEDJilg N, Giganti MJ, Chew KW, Shaw-Saliba K, Ritz J, Moser C, Evering TH, Daar ES, Eron JJ, Currier JS, Hughes MD, Lane HC, Dewar R, Smith DM, Li JZ. SARS-CoV-2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With COVID-19. Clin Infect Dis. 2024 Oct 15;79(4):920-927. doi: 10.1093/cid/ciae324.
PMID: 39018444DERIVEDHirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PMID: 35713300DERIVEDChew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs R, Ritz J, Giganti M, Javan AC, Li Y, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19: A Phase 2 Randomized Clinical Trial. medRxiv [Preprint]. 2021 Dec 21:2021.12.17.21268009. doi: 10.1101/2021.12.17.21268009.
PMID: 34981077DERIVEDKreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PMID: 34473343DERIVED
Related Links
- FDA Safety Alerts and Recalls
- CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
- A Participant's Guide to Clinical Trials (NIAID)
- Find a Clinical Trial (NIAID)
- Clinical Trials at NIAID
- National Institute for Allergy and Infectious Diseases (NIAID)
- WHO COVID-19 treatment guidelines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- ACTG Clinicaltrials.gov Coordinator
- Organization
- ACTG Network Coordinating Center, DLH
Study Officials
- STUDY CHAIR
David Smith, MD, MAS
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 19, 2020
Study Start
August 19, 2020
Primary Completion
April 7, 2022
Study Completion
June 20, 2023
Last Updated
August 2, 2024
Results First Posted
July 27, 2023
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Access Criteria
- NIAID OCICB requires a Data Use Agreement be signed by investigators seeking to obtain the PUD.
Individual patient level data are available from ACTIV-2 clinical trial in accessclinicaldata@NIAID, a NIAID cloud-based secure controlled access data platform that enables sharing of and access to data sets from clinical trials for basic and clinical research and requires a data access request and a signed data use agreement.