Official Title
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
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.

Detailed Description

Part B of this study was not conducted.

Completed
Coronavirus Disease-2019 (COVID-19)

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hungary
Israel
Netherlands
Puerto Rico
United States
Locations

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

NCT Number
Keywords
Coronavirus Disease-2019
Covid-19
Severe Acute Respiratory Syndrome Coronavirus-2
SARS-CoV-2
ABBV-47D11
ABBV-2B04
MeSH Terms
COVID-19
Coronavirus Infections