Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
Enrollment
Sex
Ages
Volunteers
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
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Women who are breastfeeding
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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
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History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
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Prior exposure to BMS-188667 (abatacept)
Other protocol-defined inclusion/exclusion criteria apply
Trial design
Primary purpose
Allocation
Interventional model
Masking
61 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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