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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID IM101-873  |   NCT04472494

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

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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 Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Abatacept + Standard of care

ASSIGNED INTERVENTION
  • Biological: Abatacept

Study Arms

Placebo Comparator: Placebo infusion + Standard of care

ASSIGNED INTERVENTION
  • Other: Placebo