Official Title
Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
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 study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.

Unknown status
COVID-19

Biological: Convalescent plasma

The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Brazil
Locations

D'Or Institute for Research and Education
Rio de Janeiro, Brazil

Investigator: Eduardo M Rego, MD, PhD

Investigator: Eduardo M Rego, MD, PhD

Contacts

Eduardo M Rego, MD, PhD
55 16 981110090
edumrego@hotmail.com

Abel Costa Neto, MD
55 11 964999091
abel.neto@oncologiador.com.br

Eduardo M Rego, MD, PhD, Principal Investigator
D'Or Institute for Research and Education

Hospital do Coracao
NCT Number
Keywords
Convalescent plasma
SARS-CoV-2
MeSH Terms
COVID-19
Pneumonia