Abatacept for Patients With COVID-19 and Respiratory Distress

Phase 1

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: Abatacept

• Registration Number: NCT04477642
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2020-04-22
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20
• Study Start: 2020-08
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AbataceptTreatment Arm	Abatacept	Enrolled patients who will receive treatment with abatacept

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation-free survival	30 days	Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept

Secondary Outcome Measures

Name	Time	Method
Duration of days on a ventilator	30 days	Number of days a patient is on a ventilator, if applicable
Days until pulse oxygen is > 93% on room air	30 days	Number of days until patient recovers with SpO2 \> 93%
Viral load	28 days	Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.
Days until supplemental oxygen is no longer required	30 days	No supplemental oxygen for at least 24 hours
Duration of fever >= 38°C	30 days	Number of days until fever is less than 38°C
Overall survival	90 days	Patient survival status through 90 days
Infusion reactions	14 days	Number of Infusion Reactions in patients treated with abatacept
Secondary infections	90 days	Number of Secondary infections in patients treated with abatacept
Radiographic Improvement	14 days	Improvement in lung findings based on CXR (chest x-ray)
Change in Clinical Status, based on 7-point ordinal scale	14 days	Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States