COVID-19 Convalescent Plasma Therapy

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-01-10

Brief Summary

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This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 \[COVID-19\] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).

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Detailed Description

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Conditions

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SARS-CoV-2 Infection COVID-19 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Convalescent plasma

COVID-19 convalescent plasma

Group Type EXPERIMENTAL

Convalescent plasma

Intervention Type BIOLOGICAL

COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2

Interventions

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Convalescent plasma

COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 18 Years and older
* Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
* Patients with no more than 15 days from the onset of symptoms
* Signed informed consent

Exclusion Criteria

* Severely ill patients admitted directly to the ICU.
* Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
* History of previous hypersensitivity to plasma transfusions.
* History of immunoglobulin A (IgA) deficiency
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No