The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
Biological: Abatacept
Specified dose on specified days
Other Name: Array
Other: Placebo
Specified dose on specified days
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
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