Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support

D'Or Institute for Research and Education

Status and phase

Unknown

Phase 2

Conditions

COVID-19

Treatments

Biological: Convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04528368

34651120.8.0000.5249

Details and patient eligibility

About

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 study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.