Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

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

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

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