Study Stopped
Slow accrual
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
2 other identifiers
interventional
61
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Oct 2020
Typical duration for phase_2 covid19
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2021
CompletedResults Posted
Study results publicly available
October 7, 2022
CompletedOctober 7, 2022
September 1, 2022
10 months
July 14, 2020
August 10, 2022
September 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28
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.
From first dose to 28 days post first dose
Secondary Outcomes (7)
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Baseline and on Day 28
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
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
- +2 more secondary outcomes
Study Arms (2)
Abatacept + Standard of care
EXPERIMENTALPlacebo infusion + Standard of care
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Alternative Research Associates, Llc
Hialeah, Florida, 33012, United States
Alternative Research Associates
Hialeah, Florida, 33012, United States
Norton Infectious Disease Institute
Louisville, Kentucky, 40202, United States
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
Local Institution - 0002
Boston, Massachusetts, 02215, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
Methodist Health System Clinical Research Institute (MHSCRI)
Dallas, Texas, 75203, United States
CardioPulmonary Research
Guaynabo, 00968, Puerto Rico
Ponce Medical School Foundation
Ponce, 00780, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 15, 2020
Study Start
October 14, 2020
Primary Completion
August 12, 2021
Study Completion
September 13, 2021
Last Updated
October 7, 2022
Results First Posted
October 7, 2022
Record last verified: 2022-09