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

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ClinicalTrials.gov Identifier: NCT04472494
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Biological: Abatacept Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 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 : August 24, 2020
Estimated Primary Completion Date : January 13, 2021
Estimated Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abatacept + Standard of care Biological: Abatacept
Specified dose on specified days
Other Names:
  • ORENCIA®
  • BMS-188667
Placebo Comparator: Placebo infusion + Standard of care Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with composite end point of mechanical ventilation or death prior to or on Day 28 [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Change from baseline in the Ordinal 8-point Outcome Scale on Day 28 [ Time Frame: Day 28 ]
  2. All-cause mortality on Day 28 [ Time Frame: Day 28 ]
  3. Proportion of participants alive and free of respiratory failure on Day 28 [ Time Frame: Day 28 ]
  4. Proportion of participants returned to room air by Day 28 [ Time Frame: Up to 28 days ]
  5. Proportion of participants alive and discharged home by Day 28 [ Time Frame: Up to 28 days ]
  6. Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 60 days ]
  7. Proportion of participants with serious infections [ Time Frame: Up to 60 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, Kentucky
Norton Infectious Disease Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Paul Schulz, Site 0004    502-394-5653      
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Site 0003         
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0002         
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Eric Whitman, Site 0001    201-572-9943      
Local Institution Withdrawn
New Brunswick, New Jersey, United States, 08901
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75203
Contact: Site 0009         
Puerto Rico
Local Institution Not yet recruiting
Guaynabo, Puerto Rico, 00968
Contact: Site 0006         
Local Institution Not yet recruiting
Monterrey Ponce, Puerto Rico, 00731
Contact: Site 0008         
Local Institution Not yet recruiting
San Juan, Puerto Rico, 00927
Contact: Site 0007         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Coronavirus disease 2019 (COVID-19)
Coronavirus
Coronavirus infections
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Additional relevant MeSH terms:
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Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents