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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Terminated
Phase 2

Conditions

COVID-19
SARS-CoV-2

Treatments

Biological: Abatacept
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04472494
IM101-873
U1111-1250-4217 (Other Identifier)

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

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

61 participants in 2 patient groups, including a placebo group

Abatacept + Standard of care
Experimental group
Treatment:
Biological: Abatacept
Placebo infusion + Standard of care
Placebo Comparator group
Treatment:
Other: Placebo

Trial documents
2

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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