Status:
UNKNOWN
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Lead Sponsor:
D'Or Institute for Research and Education
Collaborating Sponsors:
Hospital do Coracao
Conditions:
COVID-19
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present ...
Eligibility Criteria
Inclusion
- Recipient
- Confirmed diagnosis of COVID-19 by RT-PCR;
- Time between symptom onset and inclusion ≤ 7 days;
- Chest tomography with \<50% involvement of the lung parenchyma;
- No indication of ventilatory support at the time of randomization;
- Sign the consent form.
- Recipient
Exclusion
- Contraindication to transfusion or history of previous reactions to blood products for transfusion;
- Pregnant women;
- Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
- Donor Inclusion Criteria for Plasmapheresis:
- Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
- SARS-COV-2 negative RT-PCR;
- Asymptomatic for at least 14 days;
- SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
- Sign the consent form.
- Donor
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04528368
Start Date
December 11 2020
End Date
January 30 2022
Last Update
August 6 2021
Active Locations (1)
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1
D'Or Institute for Research and Education
Rio de Janeiro, Brazil