Status:
TERMINATED
Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
COVID
Infectious Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with CO...
Detailed Description
Investigators are doing this research to learn more about high-titer COVID-19 convalescent plasma (HT-CCP) transfusion as a possible treatment for people who have COVID-19, the coronavirus infection. ...
Eligibility Criteria
Inclusion
- Age \>1 year.
- Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
- Meets institutional criteria for admission to hospital for COVID-19.
- Admitted to ICU or non-ICU floor within 5 days of enrollment.
- PaO2/FiO2 \>200 mmHg if intubated.
- Patient or LAR able to provide informed consent.
Exclusion
- Previous treatment with convalescent plasma for COVID-19.
- Current use of investigational antiviral therapy targeting SARS-CoV-2.
- History of anaphylactic transfusion reaction.
- Clinical diagnosis of acute decompensated heart failure.
- Objection to blood transfusion.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04361253
Start Date
April 30 2020
End Date
June 30 2021
Last Update
August 13 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115