Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

Bristol-Myers Squibb10 sites in 2 countries61 target enrollmentOctober 14, 2020

ConditionsCOVID-19 SARS-CoV-2

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Bristol-Myers Squibb
Enrollment: 61
Locations: 10
Primary Endpoint: Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2020

End Date

September 13, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28

Time Frame: From first dose to 28 days post first dose

The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.

Secondary Outcomes

Percentage of Participants Who Died(From first dose to 28 days post first dose)
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3(Day 28±3)
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28(Baseline and on Day 28)
Percentage of Participants Returned to Room Air on Day 28(Day 28)
Percentage of Participants Alive and Discharged From the Hospital by Day 28(From day 1 up to day 28)
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class(From first dose to 60 days post first dose)
Percentage of Participants With Serious Adverse Events(From first dose to 60 days post first dose)