Abatacept for Patients With COVID-19 and Respiratory Distress
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AbataceptTreatment Arm |
Enrolled patients who will receive treatment with abatacept |
|
Recruiting Locations
More Details
- NCT ID
- NCT04477642
- Status
- Withdrawn
- Sponsor
- Beth Israel Deaconess Medical Center
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. Abatacept will be administered on Day 1 at a dose of 10 mg/kg. Patients will then be followed closely through 90 days post-treatment.