Abatacept for Patients With COVID-19 and Respiratory Distress

Beth Israel Lahey Health

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Drug: Abatacept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04477642

2020-P-00XXX

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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