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.
Part B of this study was not conducted.
Drug: ABBV-47D11
Intravenous (IV) infusion.
Drug: Placebo for ABBV-47D11
Intravenous (IV) infusion.
Drug: ABBV-2B04
Intervenous (IV) Infusion
Drug: Placebo for ABBV-2B04
Intervenous (IV) Infusion
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.
Glendale Adventist Medical Center /ID# 225188
Glendale, California, United States
Beautiful Minds Clinical Research Center /ID# 228708
Cutler Bay, Florida, United States
University of Miami /ID# 225038
Miami, Florida, United States
Triple O Research Institute /ID# 228612
West Palm Beach, Florida, United States
University of Illinois Hospital and Health Sciences System /ID# 224323
Chicago, Illinois, United States
Pikeville Medical Center /ID# 224539
Pikeville, Kentucky, United States
Saint Peter's University Hospital /ID# 225183
New Brunswick, New Jersey, United States
Saint Michael's Medical Center /ID# 225258
Newark, New Jersey, United States
The Christ Hospital /ID# 224541
Cincinnati, Ohio, United States
Prisma Health Children's Hospital Upstate /ID# 224556
Greenville, South Carolina, United States
Gadolin Research, LLC /ID# 229394
Beaumont, Texas, United States
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015
Budapest, Hungary
Semmelweis Egyetem /ID# 226016
Budapest, Hungary
Hadassah Medical Center-Hebrew University /ID# 225827
Jerusalem, Israel
Sheba Medical Center /ID# 225857
Tel Hashomer, Ramat Gan, Israel
Universitair Medisch Centrum Utrecht /ID# 225919
Utrecht, Netherlands
San Juan Bautista School of Medicine /ID# 225963
Caguas, Puerto Rico
Manati Medical Center /ID# 225936
Manati, Puerto Rico
ABBVIE INC., Study Director
AbbVie