- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644120
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Budapest, Hungary, 1023
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
-
Budapest, Hungary, 1085
- Semmelweis Egyetem /ID# 226016
-
-
-
-
-
Jerusalem, Israel, 91120
- Hadassah Medical Center-Hebrew University /ID# 225827
-
Tel Hashomer, Ramat Gan, Israel, 52621
- Sheba Medical Center /ID# 225857
-
-
-
-
-
Utrecht, Netherlands, 3584 CX
- Universitair Medisch Centrum Utrecht /ID# 225919
-
-
-
-
-
Caguas, Puerto Rico, 00726
- San Juan Bautista School of Medicine /ID# 225963
-
Manati, Puerto Rico, 00674
- Manati Medical Center /ID# 225936
-
-
-
-
California
-
Glendale, California, United States, 91206-4007
- Glendale Adventist Medical Center /ID# 225188
-
-
Florida
-
Cutler Bay, Florida, United States, 33157-6608
- Beautiful Minds Clinical Research Center /ID# 228708
-
Miami, Florida, United States, 33136
- University of Miami /ID# 225038
-
West Palm Beach, Florida, United States, 33407-3100
- Triple O Research Institute /ID# 228612
-
-
Illinois
-
Chicago, Illinois, United States, 60612-7232
- University of Illinois Hospital and Health Sciences System /ID# 224323
-
-
Kentucky
-
Pikeville, Kentucky, United States, 41501-1689
- Pikeville Medical Center /ID# 224539
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901-1766
- Saint Peter's University Hospital /ID# 225183
-
Newark, New Jersey, United States, 07102
- Saint Michael's Medical Center /ID# 225258
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- The Christ Hospital /ID# 224541
-
-
South Carolina
-
Greenville, South Carolina, United States, 29605-4210
- Prisma Health Children's Hospital Upstate /ID# 224556
-
-
Texas
-
Beaumont, Texas, United States, 77702-1100
- Gadolin Research, LLC /ID# 229394
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
|
Intravenous (IV) infusion.
|
Placebo Comparator: Part A: Group 1: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
|
Experimental: Part A: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
|
Intravenous (IV) infusion.
|
Placebo Comparator: Part A: Group 2: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
|
Experimental: Part A: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
|
Intravenous (IV) infusion.
|
Placebo Comparator: Part A: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
|
Experimental: Part B: Group 1: ABBV-2B04 Dose A
Participants will receive ABBV-2B04 Dose A on Day 1.
|
Intervenous (IV) Infusion
|
Experimental: Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11
Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
Intervenous (IV) Infusion
|
Placebo Comparator: Part B: Group 1: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
Intervenous (IV) Infusion
|
Experimental: Part B: Group 2: ABBV-2B04 Dose B
Participants will receive ABBV-2B04 Dose B on Day 1.
|
Intervenous (IV) Infusion
|
Experimental: Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11
Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
Intervenous (IV) Infusion
|
Placebo Comparator: Part B: Group 2: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
|
Intravenous (IV) infusion.
Intervenous (IV) Infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
Time Frame: Up to Day 106
|
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
Time Frame: Up to Day 106
|
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
|
Up to Day 106
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Serum Concentration (Cmax) of ABBV-47D11
Time Frame: Up to Day 85
|
Maximum observed serum concentration (Cmax) of ABBV-47D11.
|
Up to Day 85
|
Time to Cmax (Tmax) of ABBV-47D11
Time Frame: Up to Day 85
|
Time to maximum serum concentration 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
Time Frame: Up to Day 29
|
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
Time Frame: Up to Day 85
|
Terminal phase elimination half-life (t1/2) of ABBV-47D11.
|
Up to Day 85
|
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11
Time Frame: Up to Day 85
|
AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.
|
Up to Day 85
|
Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11
Time Frame: Up to Day 85
|
Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
|
Up to Day 85
|
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11
Time Frame: Up to Day 85
|
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.
|
Up to Day 85
|
AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Time Frame: Baseline (Day 1) through Day 29
|
Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.
|
Baseline (Day 1) through Day 29
|
Time to Negative SARS-CoV-2 by RT-PCR
Time Frame: Up to Day 29
|
Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.
|
Up to Day 29
|
Negative SARS-CoV-2 RNA by RT-PCR
Time Frame: Up to Day 15
|
Number of participants with negative SARS-CoV-2 RNA by RT-PCR.
|
Up to Day 15
|
Maximum Observed Serum Concentration (Cmax) of ABBV-2B04
Time Frame: Up to Day 85
|
Maximum observed serum concentration (Cmax) of ABBV-2B04.
|
Up to Day 85
|
Time to Cmax (Tmax) of ABBV-2B04
Time Frame: Up to Day 85
|
Time to maximum serum concentration of ABBV-2B04.
|
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-2B04
Time Frame: Up to Day 29
|
Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04.
|
Up to Day 29
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04
Time Frame: Up to Day 85
|
Terminal phase elimination half-life (t1/2) of ABBV-2B04.
|
Up to Day 85
|
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04
Time Frame: Up to Day 85
|
AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.
|
Up to Day 85
|
Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04
Time Frame: Up to Day 85
|
Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
|
Up to Day 85
|
Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04
Time Frame: Up to Day 85
|
Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.
|
Up to Day 85
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20-404
- 2020-005203-39 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on CoronaVirus Disease-2019 (COVID-19)
-
AudibleHealth AI, Inc.Sunrise Research Institute; Analytical Solutions Group, Inc.; Kelley Medical... and other collaboratorsCompletedCoronavirus Disease 2019 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19 | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV DiseaseUnited States
-
Leidos Life SciencesUnited States Department of DefenseWithdrawnCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV-2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV Infection
-
Leidos Life SciencesUnited States Department of DefenseTerminatedCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV InfectionUnited States
-
Leidos Life SciencesUnited States Department of DefenseActive, not recruitingCOVID-19 | Covid19 | Coronavirus Disease 2019 | SARS-CoV-2 Infection | SARS-CoV-2 Acute Respiratory Disease | COVID-19 Pandemic | COVID-19 Virus Infection | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV Disease | 2019-nCoV InfectionUnited States
-
CSL BehringCompletedCoronavirus Disease 2019 (COVID-19)United States
-
Guangzhou Institute of Respiratory DiseaseTongji Hospital; Guangzhou Eighth People's Hospital; Guangzhou Cellgenes Biotechnology...UnknownCoronavirus Disease 2019 (COVID-19)China
-
Akesobio Australia Pty LtdCompletedCoronavirus Disease 2019 (COVID-19)New Zealand
-
I-Mab Biopharma Co. Ltd.CompletedCoronavirus Disease 2019 COVID-19United States
-
Prothione, LLCCompletedCoronavirus Disease 2019 (COVID-19)Rwanda
Clinical Trials on ABBV-47D11
-
AbbVieCompletedCystic FibrosisUnited States, Belgium, Canada, Czechia, France, Hungary, Netherlands, New Zealand, Poland, Slovakia, United Kingdom, Serbia
-
AbbVieTerminated
-
AbbVieActive, not recruitingB-cell LymphomaIsrael, Puerto Rico, Turkey
-
AbbVieCompletedAdvanced Solid Tumors CancerUnited States, France, Japan, Puerto Rico, Spain, Taiwan
-
AbbVieWithdrawnParkinson's DiseaseUnited States, Puerto Rico
-
AbbVieRecruitingHealthy Volunteers | Generalized Anxiety Disorder (GAD) | Bipolar Disorder (BPD)United States
-
AbbVieCompletedHuman Immunodeficiency Virus (HIV)United States, Puerto Rico
-
AbbVieCompleted
-
AbbVieRecruiting