Overview

Abatacept for Patients With COVID-19 and Respiratory Distress

Status:
Withdrawn
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
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 Phase: Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborators:
Boston Children's Hospital
Boston Children’s Hospital
Brigham and Women's Hospital
Bristol-Myers Squibb
Treatments:
Abatacept
Criteria
Inclusion Criteria:

- Must be at least 18 years old.

- Confirmed SARS-CoV-2 infection, confirmed by polymerase chain reaction (PCR) prior to enrollment

- Evidence of respiratory distress including SpO2
- 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