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

Purpose

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

Conditions

  • COVID-19
  • SARS-CoV-2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Abatacept + Standard of care
  • Biological: Abatacept
    Specified dose on specified days
    Other names:
    • ORENCIA®
    • BMS-188667
Placebo Comparator
Placebo infusion + Standard of care
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

More Details

NCT ID
NCT04472494
Status
Terminated
Sponsor
Bristol-Myers Squibb