Official Title
Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.

Terminated
COVID-19
SARS-CoV-2

Biological: Abatacept

Specified dose on specified days
Other Name: Array

Other: Placebo

Specified dose on specified days

Eligibility Criteria

Inclusion Criteria:

- A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).

- Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)

- Respiratory compromise as defined by requirement of oxygen supplementation to maintain
oxygen saturation ≥ 93% but not requiring mechanical ventilation

- Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical
condition that would serve as an exclusionary criteria

- Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

- Women who are breastfeeding

- Recent acute infection defined as:

i) Any acute infection within 60 days prior to randomization that required
hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii)
Any acute infection within 30 days prior to randomization that required oral
antimicrobial or antiviral therapy

- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
osteomyelitis, bronchiectasis)

- Prior exposure to BMS-188667 (abatacept)

Other protocol-defined inclusion/exclusion criteria apply

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

Alternative Research Associates, Llc
Hialeah, Florida, United States

Alternative Research Associates
Hialeah, Florida, United States

Norton Infectious Disease Institute
Louisville, Kentucky, United States

Boston Childrens Hospital
Boston, Massachusetts, United States

Local Institution - 0002
Boston, Massachusetts, United States

Atlantic Health System
Morristown, New Jersey, United States

Methodist Health System Clinical Research Institute (MHSCRI)
Dallas, Texas, United States

CardioPulmonary Research
Guaynabo, Puerto Rico

Ponce Medical School Foundation
Ponce, Puerto Rico

Fundacion de Investigacion de Diego
San Juan, Puerto Rico

Bristol-Myers Squibb, Study Director
Bristol-Myers Squibb

Bristol-Myers Squibb
NCT Number
Keywords
Coronavirus Disease 2019 (COVID-19)
Coronavirus
Coronavirus Infections
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
MeSH Terms
COVID-19
Abatacept