Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04472494 |
Recruitment Status :
Terminated
(Slow accrual)
First Posted : July 15, 2020
Last Update Posted : July 8, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 SARS-CoV-2 | Biological: Abatacept Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise |
Actual Study Start Date : | October 14, 2020 |
Actual Primary Completion Date : | August 12, 2021 |
Actual Study Completion Date : | September 15, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Abatacept + Standard of care |
Biological: Abatacept
Specified dose on specified days
Other Names:
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Placebo Comparator: Placebo infusion + Standard of care |
Other: Placebo
Specified dose on specified days |
- Proportion of participants with composite end point of mechanical ventilation or death prior to or on Day 28 [ Time Frame: Up to 28 days ]
- Change from baseline in the Ordinal 8-point Outcome Scale on Day 28 [ Time Frame: Day 28 ]
- All-cause mortality on Day 28 [ Time Frame: Day 28 ]
- Proportion of participants alive and free of respiratory failure on Day 28 [ Time Frame: Day 28 ]
- Proportion of participants returned to room air by Day 28 [ Time Frame: Up to 28 days ]
- Proportion of participants alive and discharged home by Day 28 [ Time Frame: Up to 28 days ]
- Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 60 days ]
- Proportion of participants with serious infections [ Time Frame: Up to 60 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472494
United States, Florida | |
Alternative Research Associates, Llc | |
Hialeah, Florida, United States, 33012 | |
Alternative Research Associates | |
Hialeah, Florida, United States, 33012 | |
United States, Kentucky | |
Norton Infectious Disease Institute | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Boston Childrens Hospital | |
Boston, Massachusetts, United States, 02115 | |
Local Institution - 0002 | |
Boston, Massachusetts, United States, 02215 | |
United States, New Jersey | |
Atlantic Health System | |
Morristown, New Jersey, United States, 07960 | |
United States, Texas | |
Methodist Health System Clinical Research Institute (MHSCRI) | |
Dallas, Texas, United States, 75203 | |
Puerto Rico | |
CardioPulmonary Research | |
Guaynabo, Puerto Rico, 00968 | |
Ponce Medical School Foundation | |
Ponce, Puerto Rico, 00780 | |
Fundacion de Investigacion de Diego | |
San Juan, Puerto Rico, 00927 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04472494 |
Other Study ID Numbers: |
IM101-873 U1111-1250-4217 ( Other Identifier: WHO ) |
First Posted: | July 15, 2020 Key Record Dates |
Last Update Posted: | July 8, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus disease 2019 (COVID-19) Coronavirus Coronavirus infections Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Abatacept Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |