Status:
COMPLETED
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
State of Maryland
Bloomberg Philanthropies
Conditions:
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal vir...
Detailed Description
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatie...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Competent and capable to provide informed consent
- • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab
- Experiencing any symptoms of COVID-19 including but not limited to fever(T\> 100.5º F), cough, or other COVID associated symptoms like anosmia
- ≤ 8 days since the first symptoms of COVID-19
- ≤ 8 days since first positive SARS-CoV-2 RNA test
- Able and willing to comply with protocol requirements listed in the informed consent
Exclusion
- Hospitalized or expected to be hospitalized within 24 hours of enrollment
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
- History of prior reactions to transfusion blood products
- Inability to complete therapy with the study product within 24 hours after enrollment
- Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
1225 Patients enrolled
Trial Details
Trial ID
NCT04373460
Start Date
June 3 2020
End Date
December 14 2022
Last Update
June 2 2023
Active Locations (29)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Center for American Indian Health - Chinle Office
Chinle, Arizona, United States, 86503
3
Mayo Clinic, Phoenix
Phoenix, Arizona, United States, 85054
4
University of Arizona, Phoenix
Tucson, Arizona, United States, 85719