Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
3 other identifiers
interventional
4,891
15 countries
183
Brief Summary
The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Mar 2020
Shorter than P25 for phase_3 covid19
183 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
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
March 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedResults Posted
Study results publicly available
December 31, 2020
CompletedDecember 31, 2020
December 1, 2020
1 month
February 28, 2020
December 15, 2020
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14
Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.
Day 14
Secondary Outcomes (1)
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
First dose date up to last dose date (maximum: 10 days) plus 30 days
Study Arms (4)
Part A: Remdesivir (RDV), 5 Days
EXPERIMENTALParticipants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Part A: Remdesivir, 10 Days
EXPERIMENTALParticipants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Part B: Remdesivir, 10 Days (Extension)
EXPERIMENTALPart B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.
Part B: Remdesivir 10 days (Mechanically Ventilated)
EXPERIMENTALParticipants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
Interventions
Administered as an intravenous infusion
Standard of Care Treatment for COVID-19 Infection
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to \< 18, where locally and nationally approved) prior to performing study procedures
- Aged ≥ 18 years (at all sites), or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
- Currently hospitalized
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening
You may not qualify if:
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited \< 24 hours prior to study drug dosing
- Evidence of multiorgan failure
- Mechanically ventilated \[including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)\] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
- Creatinine clearance \< 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants \< 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (183)
Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue
Anaheim, California, 92806, United States
Alta Bates Summit Medical Center
Berkeley, California, 94609, United States
Mills-Peninsula Medical Center
Burlingame, California, 94010, United States
Eden Medical Center
Castro Valley, California, 94546, United States
Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway
Downey, California, 90241, United States
Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave
Fontana, California, 92335, United States
St Joseph Hospital Eureka
Fortuna, California, 95540, United States
Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.
Harbor City, California, 90710, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.
Los Angeles, California, 90034, United States
Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue
Los Angeles, California, 91365, United States
Mission Hospital Regional Medical Center
Mission Viejo, California, 92691, United States
Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue
Moreno Valley, California, 92555, United States
El Camino Hospital
Mountain View, California, 94040, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611, United States
Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue
Ontario, California, 91761, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange, California, 92868, United States
Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street
Panorama City, California, 91402, United States
Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue
Riverside, California, 92505, United States
Sutter Medical Center Sacramento, One Medical Plaza
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95815, United States
Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue
San Diego, California, 92120-2507, United States
Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd
San Diego, California, 92123, United States
Kaiser Permanente Oakland Medical Center, 1200 El Camino Real
San Francisco, California, 94080, United States
California Pacific Medical Center-Infectious Disease Associates Medical Group
San Francisco, California, 94109, United States
Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd
San Francisco, California, 94115, United States
Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850
San Jose, California, 95119, United States
Kaiser Permanente Oakland Medical Center, 2500 Merced St
San Leandro, California, 94577, United States
Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway
Santa Clara, California, 95051, United States
Providence St. Johns Medical Center
Santa Monica, California, 90404, United States
Sutter Santa Rosa Regional Hospital
Santa Rosa, California, 95403, United States
Stanford Hospital
Stanford, California, 94305, United States
University of Colorado Denver, University of Colorado Hospital
Aurora, Colorado, 80045, United States
SCL Health St. Joseph Hospital, 1375 East 19th Ave
Denver, Colorado, 80208, United States
SCL Health St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
SCL Health St. Joseph Hospital, 200 Exempla Circle.
Lafayette, Colorado, 80026, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46077, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Maine Medical Center
Portland, Maine, 04102, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham & Women's Hospital and Harvard Medical School
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
The University of Michigan Hospitals and Health Systems
Ann Arbor, Michigan, 48109-5378, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Providence St Patrick Hospital and International Heart Institute of MT Foundation
Missoula, Montana, 59802, United States
Darmouth-Hitchhock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Robert Wood Johnson University Hospital Somerset
Hillsborough, New Jersey, 08844, United States
Robert Wood Johnson University Hospital Somerset, 1 RWJ Place
New Brunswick, New Jersey, 08901, United States
Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue
Newark, New Jersey, 07112, United States
St. Joseph's University Medical Center
Paterson, New Jersey, 07503, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Danbury Hospital
Lagrangeville, New York, 12540, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
North Shore University Hospital, 270-05 76th Ave
New Hyde Park, New York, 11040, United States
Icahn School of Medicine at Mount Sinai, 350 East 17th Street
New York, New York, 10003, United States
Icahn School of Medicine at Mount Sinai, 1000 10th Avenue
New York, New York, 10019, United States
Icahn School of Medicine at Mount Sinai, 440 West 114th St.
New York, New York, 10025, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
James J. Peters Veterans Administration Medical Center
The Bronx, New York, 10468, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave
Hillsboro, Oregon, 97124, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Kaiser Sunnyside Medical Center
Portland, Oregon, 97227, United States
Hospital of the University of Pennsylvania, 51 N. 31st Street
Philadelphia, Pennsylvania, 19104, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
Prisma Health Richland Hospital, 701 Grove Road
Greenville, South Carolina, 29605, United States
The Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic
Dallas, Texas, 75235, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.
Dallas, Texas, 75390, United States
UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd
Dallas, Texas, 75390, United States
Baylor University Medical Center, 1400 8th Ave
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Baylor University Medical Center, 2401 S. 31st St.
Temple, Texas, 76508, United States
University of Utah Health
Salt Lake City, Utah, 84132, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
VCU Health Medical Center
Richmond, Virginia, 23298, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Kadlec Regional Medical Center
Kennewick, Washington, 99336, United States
Providence St. Peter Hospital
Olympia, Washington, 98506, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Center for Comprehensive Care
Seattle, Washington, 98104, United States
MultiCare Deaconess Hospital
Spokane, Washington, 99204, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
St Joseph Medical Center
Tacoma, Washington, 98405, United States
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
CHU Pellegrin
Bordeaux, 33076, France
CHU de Montpellier-Hopital Gui de Chauliac
Montpelier Cedex 5, 34295, France
CHU de Nantes-Hotel Dieu
Nantes, 44035, France
Hopital Saint-Louis
Paris, 75010, France
Hopital Saint Antoine
Paris, 75012, France
Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie
Berlin, 13353, Germany
Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie
Düsseldorf, 40225, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105, Germany
Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie
Leipzig, 4129, Germany
Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2
Munich, 81675, Germany
Klinik für Hämatologie, Onkologie, Immunologie
München, 80804, Germany
Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)
Stuttgart, 70376, Germany
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
UOC Malattie Infettive, ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
ASST di Cremona - Azienda Socio Sanitaria Territor
Cremona, 26100, Italy
UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
UOC Malattie Infettive, IRCCS Ospedale San Raffaele
Milan, 20127, Italy
Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco
Milan, 20157, Italy
UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova
Padova PD, 35121, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, 43126, Italy
UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo
Pavia, 27100, Italy
Ospedale Guglielmo da Saliceto AUSL di Piacenza
Piacenza, Italy
UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma, 00149, Italy
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
Torino, 10149, Italy
Yokohama Municipal Citizen's Hospital
Kanagawa, 240-8555, Japan
Nagoya City East Medical Center
Nagoya, 464-8547, Japan
Tokyo Metropolitan Bokutoh Hospital
Tokyo, 130-8575, Japan
Amsterdam University Medical Centre - Location AMC
Amsterdam, 1105 AZ, Netherlands
Leiden University Medical Center
Leiden, 2300 RC, Netherlands
Erasmus Medical Centre
Rotterdam, 3015 GD, Netherlands
National University Hospital
Singapore, 119228, Singapore
Singapore General Hospital
Singapore, 169856, Singapore
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Singapore, 308442, Singapore
Kyungpook National University Hospital
Daegu, 41944, South Korea
Seoul Medical Center
Seoul, 02053, South Korea
National Medical Center
Seoul, 04564, South Korea
Hospital Principe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Universitario Cruces
Bizkaia, 48903, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Sahlgrenska University Hospital, Ostra
Gothenburg, 41685, Sweden
SUS (Skanes University Hospital)
Malmo, 20502, Sweden
Karolinska University Hospital
Stockholm, SE-141 86, Sweden
Hopitaux Universitaires de Genève
Geneva, 1211, Switzerland
Ospedale Regionale di Locarno La Carità
Lugano, CH- 6900, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Imperial College Healthcare NHS Trust
London, Greater London, W2 1NY, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, HU16 5JQ, United Kingdom
Royal Lancaster Hospital
Lancaster, LA1 4RP, United Kingdom
Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Northwick Park Hospital
London, HA1 3UJ, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
King's College Hospital NHS Trust
London, SE5 9RS, United Kingdom
University College London
London, WC1E 6JF, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M23 9LT, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB, United Kingdom
Derriford Hospital
Plymouth, PL6 8BG, United Kingdom
Sheffield Teaching Hospitals
Sheffield, S10 2JF, United Kingdom
Related Publications (4)
Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.
PMID: 32459919BACKGROUNDFusco D, Malenica I, Gunthard HF, Gupta SK, Kurbegov D, Balani B, Olender S, Aberg JA, Telep LE, Tian Y, Blair C, Wu G, Haubrich RH, Wang CY, Chokkalingam AP, Osinusi AO, Wendtner CM, Gottlieb RL. Remdesivir for Treatment of COVID-19 Requiring Oxygen Support: A Cross-Study Comparison From 2 Large, Open-Label Studies. Clin Infect Dis. 2024 Nov 22;79(5):1182-1189. doi: 10.1093/cid/ciae336.
PMID: 38920297DERIVEDJacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.
PMID: 33624010DERIVEDOlender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.
PMID: 32706859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 28, 2020
First Posted
March 3, 2020
Study Start
March 6, 2020
Primary Completion
April 9, 2020
Study Completion
June 30, 2020
Last Updated
December 31, 2020
Results First Posted
December 31, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.