CD2H COVID-19

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)

Purpose

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.

Condition

CoronaVirus Disease-2019 (COVID-19)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Group 1: ABBV-47D11 Dose A	Participants will receive ABBV-47D11 Dose A on Day 1.	Drug: ABBV-47D11 Intravenous (IV) infusion.
Placebo Comparator Part A: Group 1: Placebo for ABBV-47D11	Participants will receive placebo for ABBV-47D11 on Day 1.	Drug: Placebo for ABBV-47D11 Intravenous (IV) infusion.
Experimental Part A: Group 2: ABBV-47D11 Dose B	Participants will receive ABBV-47D11 Dose B on Day 1.	Drug: ABBV-47D11 Intravenous (IV) infusion.
Placebo Comparator Part A: Group 2: Placebo for ABBV-47D11	Participants will receive placebo for ABBV-47D11 on Day 1.	Drug: Placebo for ABBV-47D11 Intravenous (IV) infusion.
Experimental Part A: Group 3: ABBV-47D11 Dose C	Participants will receive ABBV-47D11 Dose C on Day 1.	Drug: ABBV-47D11 Intravenous (IV) infusion.
Placebo Comparator Part A: Group 3: Placebo for ABBV-47D11	Participants will receive placebo for ABBV-47D11 on Day 1.	Drug: Placebo for ABBV-47D11 Intravenous (IV) infusion.
Experimental Part B: Group 1: ABBV-2B04 Dose A	Participants will receive ABBV-2B04 Dose A on Day 1.	Drug: ABBV-2B04 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.	Drug: ABBV-47D11 Intravenous (IV) infusion. Drug: ABBV-2B04 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.	Drug: Placebo for ABBV-47D11 Intravenous (IV) infusion. Drug: Placebo for ABBV-2B04 Intervenous (IV) Infusion
Experimental Part B: Group 2: ABBV-2B04 Dose B	Participants will receive ABBV-2B04 Dose B on Day 1.	Drug: ABBV-2B04 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.	Drug: ABBV-47D11 Intravenous (IV) infusion. Drug: ABBV-2B04 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.	Drug: Placebo for ABBV-47D11 Intravenous (IV) infusion. Drug: Placebo for ABBV-2B04 Intervenous (IV) Infusion

Recruiting Locations

More Details

NCT ID: NCT04644120
Status: Completed
Sponsor: AbbVie

Detailed Description

Part B of this study was not conducted.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.