Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
NCT ID: NCT04472494
Last Updated: 2022-10-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
61 participants
INTERVENTIONAL
2020-10-14
2021-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Abatacept + Standard of care
Abatacept
Specified dose on specified days
Placebo infusion + Standard of care
Placebo
Specified dose on specified days
Interventions
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Abatacept
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Alternative Research Associates, Llc
Hialeah, Florida, United States
Alternative Research Associates
Hialeah, Florida, United States
Norton Infectious Disease Institute
Louisville, Kentucky, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Local Institution - 0002
Boston, Massachusetts, United States
Atlantic Health System
Morristown, New Jersey, United States
Methodist Health System Clinical Research Institute (MHSCRI)
Dallas, Texas, United States
CardioPulmonary Research
Guaynabo, , Puerto Rico
Ponce Medical School Foundation
Ponce, , Puerto Rico
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Investigator Inquiry Form
Other Identifiers
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U1111-1250-4217
Identifier Type: OTHER
Identifier Source: secondary_id
IM101-873
Identifier Type: -
Identifier Source: org_study_id
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