Status:
TERMINATED
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04472494
Start Date
October 14 2020
End Date
September 13 2021
Last Update
October 7 2022
Active Locations (10)
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1
Alternative Research Associates, Llc
Hialeah, Florida, United States, 33012
2
Alternative Research Associates
Hialeah, Florida, United States, 33012
3
Norton Infectious Disease Institute
Louisville, Kentucky, United States, 40202
4
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115