Back to resultsAbatacept for Patients With COVID-19 and Respiratory Distress
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus
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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AbataceptTreatment Arm
Arm Description
Enrolled patients who will receive treatment with abatacept
Outcomes
Primary Outcome Measures
Mechanical ventilation-free survival
Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept
Secondary Outcome Measures
Duration of days on a ventilator
Number of days a patient is on a ventilator, if applicable
Days until pulse oxygen is > 93% on room air
Number of days until patient recovers with SpO2 > 93%
Days until supplemental oxygen is no longer required
No supplemental oxygen for at least 24 hours
Duration of fever >= 38°C
Number of days until fever is less than 38°C
Overall survival
Patient survival status through 90 days
Infusion reactions
Number of Infusion Reactions in patients treated with abatacept
Secondary infections
Number of Secondary infections in patients treated with abatacept
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
Viral load
Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.
Radiographic Improvement
Improvement in lung findings based on CXR (chest x-ray)
Full Information
NCT ID
NCT04477642
First Posted
April 22, 2020
Last Updated
July 16, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Boston Children's Hospital, Bristol-Myers Squibb, Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04477642
Brief Title
Abatacept for Patients With COVID-19 and Respiratory Distress
Official Title
Abatacept for Patients With COVID-19 and Respiratory Distress
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Boston Children's Hospital, Bristol-Myers Squibb, Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AbataceptTreatment Arm
Arm Type
Experimental
Arm Description
Enrolled patients who will receive treatment with abatacept
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
10mg/kg intravenously administered on Day 1
Primary Outcome Measure Information:
Title
Mechanical ventilation-free survival
Description
Cumulative incidence of mechanical ventilation-free survival at 30 days after initiation of abatacept
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of days on a ventilator
Description
Number of days a patient is on a ventilator, if applicable
Time Frame
30 days
Title
Days until pulse oxygen is > 93% on room air
Description
Number of days until patient recovers with SpO2 > 93%
Time Frame
30 days
Title
Days until supplemental oxygen is no longer required
Description
No supplemental oxygen for at least 24 hours
Time Frame
30 days
Title
Duration of fever >= 38°C
Description
Number of days until fever is less than 38°C
Time Frame
30 days
Title
Overall survival
Description
Patient survival status through 90 days
Time Frame
90 days
Title
Infusion reactions
Description
Number of Infusion Reactions in patients treated with abatacept
Time Frame
14 days
Title
Secondary infections
Description
Number of Secondary infections in patients treated with abatacept
Time Frame
90 days
Title
Change in Clinical Status, based on 7-point ordinal scale
Description
Change in clinical status from baseline, as assessed by a 7-point ordinal scale on Day 14
Time Frame
14 days
Title
Viral load
Description
Viral load at baseline and on Days 7, 14, 21, 28 (each +/- 2 days) after the first abatacept dose.
Time Frame
28 days
Title
Radiographic Improvement
Description
Improvement in lung findings based on CXR (chest x-ray)
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacalyn Rosenblatt, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Abatacept for Patients With COVID-19 and Respiratory Distress
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