Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19)
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
2 other identifiers
interventional
25
5 countries
18
Brief Summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally. In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2020
18 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
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
December 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2021
CompletedSeptember 2, 2021
August 1, 2021
9 months
November 23, 2020
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
Up to Day 106
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
Up to Day 106
Secondary Outcomes (17)
Maximum Observed Serum Concentration (Cmax) of ABBV-47D11
Up to Day 85
Time to Cmax (Tmax) of ABBV-47D11
Up to Day 85
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11
Up to Day 29
Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11
Up to Day 85
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11
Up to Day 85
- +12 more secondary outcomes
Study Arms (12)
Part A: Group 1: ABBV-47D11 Dose A
EXPERIMENTALParticipants will receive ABBV-47D11 Dose A on Day 1.
Part A: Group 1: Placebo for ABBV-47D11
PLACEBO COMPARATORParticipants will receive placebo for ABBV-47D11 on Day 1.
Part A: Group 2: ABBV-47D11 Dose B
EXPERIMENTALParticipants will receive ABBV-47D11 Dose B on Day 1.
Part A: Group 2: Placebo for ABBV-47D11
PLACEBO COMPARATORParticipants will receive placebo for ABBV-47D11 on Day 1.
Part A: Group 3: ABBV-47D11 Dose C
EXPERIMENTALParticipants will receive ABBV-47D11 Dose C on Day 1.
Part A: Group 3: Placebo for ABBV-47D11
PLACEBO COMPARATORParticipants will receive placebo for ABBV-47D11 on Day 1.
Part B: Group 1: ABBV-2B04 Dose A
EXPERIMENTALParticipants will receive ABBV-2B04 Dose A on Day 1.
Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11
EXPERIMENTALParticipants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.
Part B: Group 1: Placebo
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Part B: Group 2: ABBV-2B04 Dose B
EXPERIMENTALParticipants will receive ABBV-2B04 Dose B on Day 1.
Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11
EXPERIMENTALParticipants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.
Part B: Group 2: Placebo
PLACEBO COMPARATORParticipants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
Interventions
Intravenous (IV) infusion.
Intravenous (IV) infusion.
Intervenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.
- Must have \>= 1 symptom associated with COVID-19 with an onset of \<= 8 days prior to randomization.
- Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study
You may not qualify if:
- Have an oxygen saturation (SpO2) \< 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<= 200 mmHg at randomization.
- Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
- Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (18)
Glendale Adventist Medical Center /ID# 225188
Glendale, California, 91206-4007, United States
Beautiful Minds Clinical Research Center /ID# 228708
Cutler Bay, Florida, 33157-6608, United States
University of Miami /ID# 225038
Miami, Florida, 33136, United States
Triple O Research Institute /ID# 228612
West Palm Beach, Florida, 33407-3100, United States
University of Illinois Hospital and Health Sciences System /ID# 224323
Chicago, Illinois, 60612-7232, United States
Pikeville Medical Center /ID# 224539
Pikeville, Kentucky, 41501-1689, United States
Saint Peter's University Hospital /ID# 225183
New Brunswick, New Jersey, 08901-1766, United States
Saint Michael's Medical Center /ID# 225258
Newark, New Jersey, 07102, United States
The Christ Hospital /ID# 224541
Cincinnati, Ohio, 45219, United States
Prisma Health Children's Hospital Upstate /ID# 224556
Greenville, South Carolina, 29605-4210, United States
Gadolin Research, LLC /ID# 229394
Beaumont, Texas, 77702-1100, United States
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
Budapest, 1023, Hungary
Semmelweis Egyetem /ID# 226016
Budapest, 1085, Hungary
Hadassah Medical Center-Hebrew University /ID# 225827
Jerusalem, 91120, Israel
Sheba Medical Center /ID# 225857
Tel Hashomer, Ramat Gan, 52621, Israel
Universitair Medisch Centrum Utrecht /ID# 225919
Utrecht, 3584 CX, Netherlands
San Juan Bautista School of Medicine /ID# 225963
Caguas, 00726, Puerto Rico
Manati Medical Center /ID# 225936
Manatí, 00674, Puerto Rico
Related Publications (1)
Kreuzberger 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2020
First Posted
November 25, 2020
Study Start
December 10, 2020
Primary Completion
August 24, 2021
Study Completion
August 24, 2021
Last Updated
September 2, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share