Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT04528368
Eligibility Criteria:
Recipient Inclusion Criteria:
* 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 Criteria:
* 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 Exclusion Criteria:
* Female gender with previous pregnancy;
* Absence of peripheral venous network compatible with the apheresis procedure;
* Positive or indeterminate result in any of the infectious screening tests;
* Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04528368
Study Brief:
Protocol Section:
NCT04528368