Status:
UNKNOWN
Anti COVID-19 Convalescent Plasma Therapy
Lead Sponsor:
Orthosera Kft.
Collaborating Sponsors:
Semmelweis University
University of Pecs
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countr...
Eligibility Criteria
Inclusion
- Inclusion criteria for blood donors :
- age : \>18 and \<60 years
- body weight : \>50 kg
- confirmed previous SARS CoV-2 infection
- 2 negative SARS CoV-2 test result
- written informed consent
- neutralizing antibody titer min. 1 : 120
- Exclusion criteria for blood donors :
- age : \<18 or \>60 years
- female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
- to minimize the transfusional side effects our aim is to include mostly male donors.
- Inclusion criteria for patients/recipients :
- age : \>18 years
- admitted to hospital due to SARS CoV-2 infection
- written informed consent
- Exclusion criteria for patients/recipients :
- age : \<18 years
- female subjects who are pregnant or breastfeeding
- patients with prior allergic reaction to transfusion
- patients who received in the past 30 days immunoglobulin therapy
Exclusion
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04345679
Start Date
April 14 2020
End Date
September 1 2021
Last Update
February 25 2021
Active Locations (1)
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1
Semmelweis University's Department of Pulmonology
Budapest, Hungary, 1083