The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Alternative Research Associates, Llc
Hialeah, Florida, United States
Alternative Research Associates
Hialeah, Florida, United States
Norton Infectious Disease Institute
Louisville, Kentucky, United States
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.
Time frame: From first dose to 28 days post first dose
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: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston Childrens Hospital
Boston, Massachusetts, United States
Local Institution - 0002
Boston, Massachusetts, United States
Atlantic Health System
Morristown, New Jersey, United States
Methodist Health System Clinical Research Institute (MHSCRI)
Dallas, Texas, United States
CardioPulmonary Research
Guaynabo, Puerto Rico
Ponce Medical School Foundation
Ponce, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From first dose to 60 days post first dose