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

Phase 2

Terminated

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Other: Placebo; Biological: Abatacept

• Registration Number: NCT04472494
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-15
• Study Start: 2020-10-14
• Primary Completion: 2021-08-12
• Study Completion: 2021-09-13
• Results First Submitted: 2022-08-10
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Results First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo infusion + Standard of care	Placebo	-
Abatacept + Standard of care	Abatacept	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28	From first dose to 28 days post first dose	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Died	From first dose to 28 days post first dose	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
Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3	Day 28±3	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
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28	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: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices; 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 Baseline is defined as the last assessment done prior or on Day 1
Percentage of Participants Returned to Room Air on Day 28	Day 28	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
Percentage of Participants Alive and Discharged From the Hospital by Day 28	From day 1 up to day 28	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
Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class	From first dose to 60 days post first dose	Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)
Percentage of Participants With Serious Adverse Events	From first dose to 60 days post first dose	Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose: * Results in death; * Is life threatening; * Requires inpatient hospitalization; * Results in persistent or significant disability; * Is a congenital anomaly/birth defect; * Is an important medical event

Trial Locations

Locations (10)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States

CardioPulmonary Research; 🇵🇷 Guaynabo, Puerto Rico

Ponce Medical School Foundation; 🇵🇷 Ponce, Puerto Rico

Fundacion de Investigacion de Diego; 🇵🇷 San Juan, Puerto Rico

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

Methodist Health System Clinical Research Institute (MHSCRI); 🇺🇸 Dallas, Texas, United States