COVID-19 Convalescent Plasma Therapy

Universidad Nacional de Asunción1 site in 1 country350 target enrollmentAugust 10, 2020

ConditionsSARS-CoV-2 Infection COVID-19 Infection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: SARS-CoV-2 Infection
Sponsor: Universidad Nacional de Asunción
Enrollment: 350
Locations: 1
Primary Endpoint: Overall survival (30-day mortality)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

August 10, 2020

End Date

January 10, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universidad Nacional de Asunción

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Overall survival (30-day mortality)

Time Frame: 30 days

To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.