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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2022-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent Plasma + Standard treatment

Participants will receive the standard treatment and convalescent plasma

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

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

Standard treatment

Participants will receive the standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

* 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.

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.

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No