Abatacept for Patients With COVID-19 and Respiratory Distress

COVID-19 Clinical Trial

Official title:

Abatacept for Patients With COVID-19 and Respiratory Distress

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04477642
• Other study ID #: 2020-P-00XXX
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Abatacept
10mg/kg intravenously administered on Day 1

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Boston Children’s Hospital, Brigham and Women's Hospital, Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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