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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19, SARS-CoV-2

In brief

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

Key facts

Study ID

NCT04472494

Run by

Bristol-Myers Squibb

People needed

61

Starts

2020-10-14

Expected to finish

2021-09-13

Last updated by the study team

2022-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.