Clinical trial NCT04477642: Abatacept for Patients With COVID-19 and Respiratory Distress
Official title: Abatacept for Patients With COVID-19 and Respiratory Distress
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: Coronavirus
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Bristol-Myers Squibb
name: Brigham and Women's Hospital
First posted: 2020-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Mechanical ventilation-free survival
timeFrame: 30 days
Secondary outcomes:
measure: Duration of days on a ventilator
timeFrame: 30 days
measure: Days until pulse oxygen is > 93% on room air
timeFrame: 30 days
measure: Days until supplemental oxygen is no longer required
timeFrame: 30 days
measure: Duration of fever >= 38°C
timeFrame: 30 days
measure: Overall survival
timeFrame: 90 days
measure: Infusion reactions
timeFrame: 14 days
measure: Secondary infections
timeFrame: 90 days
measure: Change in Clinical Status, based on 7-point ordinal scale
timeFrame: 14 days
measure: Viral load
timeFrame: 28 days
measure: Radiographic Improvement
timeFrame: 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jacalyn Rosenblatt, MD
role: PRINCIPAL_INVESTIGATOR
References: