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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.

Official Title
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Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Biological: Abatacept
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abatacept + Standard of care<br> | Biological: Abatacept<br>* Specified dose on specified days<br>* Other names: BMS-188667;|
| Placebo Comparator: Placebo infusion + Standard of care<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28 | 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. | From first dose to 28 days post first dose | 

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 | 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: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1 | Baseline and on Day 28 | 
| Percentage of Participants Who Died | 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 | 
| Percentage of Participants Alive and Free of Respiratory Failure on 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 | Day 28±3 | 
| Percentage of Participants Returned to Room Air on 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 | Day 28 | 
| Percentage of Participants Alive and Discharged From the Hospital by 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 | From day 1 up to day 28 | 
| Percentage of Participants With Serious Adverse Events | 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 | 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 | Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC) | From first dose to 60 days post first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus disease 2019 (COVID-19), Coronavirus, Coronavirus infections, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)