Status:
WITHDRAWN
Abatacept for Patients With COVID-19 and Respiratory Distress
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Boston Children's Hospital
Bristol-Myers Squibb
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single-arm open label trial for hospitalized patients with COVID-19 (Coronavirus). The primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who a...
Detailed Description
Patients with COVID-19 who are admitted with respiratory distress will be considered for enrollment on this study. Patients will be screened and then if they meet eligibility criteria will be enrolled...
Eligibility Criteria
Inclusion
- Must be at least 18 years old.
- Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) \</=4 days prior to enrollment
- Evidence of respiratory distress including SpO2 \</=93% on room air.
- Radiographic evidence of pulmonary infiltrates.
- Ability to understand and the willingness to provide informed consent.
Exclusion
- Patients already intubated/mechanically ventilated at screening will not be eligible.
- Patients with uncontrolled severe bacterial or fungal infections at the time of enrollment.
- Patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing COVID-19 are not eligible
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04477642
Start Date
August 1 2020
End Date
December 1 2020
Last Update
July 20 2020
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02215