Abatacept for Patients With COVID-19 and Respiratory Distress

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04477642

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2020-08-01

Expected to finish

2020-12-01

Last updated by the study team

2020-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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