- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472494
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Guaynabo, Puerto Rico, 00968
- CardioPulmonary Research
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Ponce, Puerto Rico, 00780
- Ponce Medical School Foundation
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San Juan, Puerto Rico, 00927
- Fundacion de Investigacion de Diego
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Florida
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Hialeah, Florida, United States, 33012
- Alternative Research Associates, LLC
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Hialeah, Florida, United States, 33012
- Alternative Research Associates
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Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Infectious Disease Institute
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Childrens Hospital
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Boston, Massachusetts, United States, 02215
- Local Institution - 0002
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New Jersey
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Morristown, New Jersey, United States, 07960
- Atlantic Health System
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Texas
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Dallas, Texas, United States, 75203
- Methodist Health System Clinical Research Institute (MHSCRI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abatacept + Standard of care
|
Specified dose on specified days
Other Names:
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Placebo Comparator: Placebo infusion + Standard of care
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Specified dose on specified days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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From first dose to 28 days post first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28
Time Frame: Baseline and on Day 28
|
Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:
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Baseline and on Day 28
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Percentage of Participants Who Died
Time Frame: From first dose to 28 days post first dose
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Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 1) Death |
From first dose to 28 days post first dose
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Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3
Time Frame: Day 28±3
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Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities |
Day 28±3
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Percentage of Participants Returned to Room Air on Day 28
Time Frame: Day 28
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Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities |
Day 28
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Percentage of Participants Alive and Discharged From the Hospital by Day 28
Time Frame: From day 1 up to day 28
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Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition: 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities |
From day 1 up to day 28
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Percentage of Participants With Serious Adverse Events
Time Frame: From first dose to 60 days post first dose
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Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:
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From first dose to 60 days post first dose
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Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class
Time Frame: From first dose to 60 days post first dose
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Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
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From first dose to 60 days post first dose
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Abatacept
Other Study ID Numbers
- IM101-873
- U1111-1250-4217 (Other Identifier: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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