Status:
COMPLETED
COVID-19 Plasma Collection
Lead Sponsor:
Thomas Jefferson University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the...
Detailed Description
As described by the FDA on 3/24/2020, convalescent plasma has been used for a variety of infectious diseases including Ebola, SARS, MERS and H1N1 flu. Given that there is no current medical treatment ...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Prior diagnosis of COVID-19 documented by a laboratory test approved by the FDA
- Either: Complete resolution of all COVID-related symptoms for 14-28 days at the time of blood donation AND negative repeated SARS-CoV-2 test OR Complete resolution of all COVID-related symptoms for \> 28 days
- Male donors, never-pregnant female donors, or previously pregnant female donors negative for HLA antibodies
- Meet all criteria for volunteer blood donation per Jefferson Blood Donor Center and the FDA
Exclusion
- Failure to pass standard volunteer blood donor screening criteria required by the Jefferson Blood Donor Center and the FDA
- Female donors with HLA antibodies (per FDA requirements for convalescent plasma donors)
- Inadequate venous access for phlebotomy
- Currently pregnant
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04344015
Start Date
April 13 2020
End Date
June 2 2020
Last Update
May 10 2021
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107