Overview
Abatacept for Patients With COVID-19 and Respiratory Distress
Status:
Withdrawn
Withdrawn
Trial end date:
2020-12-01
2020-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 are admitted to the hospital with COVID-19 infection and a Pulse Oxygen Level = 93% on room air. The primary endpoint analysis will be performed using all enrolled patients.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Beth Israel Deaconess Medical CenterCollaborators:
Boston Children's Hospital
Boston Children’s Hospital
Brigham and Women's Hospital
Bristol-Myers SquibbTreatments:
Abatacept
Criteria
Inclusion Criteria:- 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 Criteria:
- 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