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)

AbbVie25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

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

...and 8 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to Day 106

Secondary Outcomes

Maximum Observed Serum Concentration (Cmax) of ABBV-47D11

Maximum observed serum concentration (Cmax) of ABBV-47D11.

Time frame: Up to Day 85

Time to Cmax (Tmax) of ABBV-47D11

Time to maximum serum concentration of ABBV-47D11.

Time frame: 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

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

Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11

Terminal phase elimination half-life (t1/2) of ABBV-47D11.

Time frame: Up to Day 85

AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11

AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.

Time frame: Up to Day 85

Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11

Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.

Time frame: Up to Day 85

Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11

Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.

Time frame: 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)

Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.

Time frame: Baseline (Day 1) through Day 29

Time to Negative SARS-CoV-2 by RT-PCR

Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.

Time frame: Up to Day 29

Negative SARS-CoV-2 RNA by RT-PCR

Number of participants with negative SARS-CoV-2 RNA by RT-PCR.

Time frame: Up to Day 15

Maximum Observed Serum Concentration (Cmax) of ABBV-2B04

Maximum observed serum concentration (Cmax) of ABBV-2B04.

Time frame: Up to Day 85

Time to Cmax (Tmax) of ABBV-2B04

Time to maximum serum concentration of ABBV-2B04.

Time frame: 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

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

Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04

Terminal phase elimination half-life (t1/2) of ABBV-2B04.

Time frame: Up to Day 85

AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04

AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.

Time frame: Up to Day 85

Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04

Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.

Time frame: Up to Day 85

Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04

Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.

Time frame: Up to Day 85

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)

Overview

Conditions

Interventions

Eligibility

Locations (18)

Outcomes

Primary Outcomes

Secondary Outcomes