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Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

NCT04332835•Universidad del Rosario

View on ClinicalTrials.gov

Summary

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

Detailed Description

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Olerder than 18.
•2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
•3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
•4. Sequential Organ Failure Assessment score (SOFA) \< 6.
•5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•1. Female subjects who are pregnant or breastfeeding.
•2. Patients with prior allergic reactions to transfusions.
•3. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
•4. Patients with surgical procedures in the last 30 days.
•5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
•6. HIV diagnosed patients with viral failure (detectable viral load\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
•7. Demonstrated coinfection that explains the patient's symptoms
•8. End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
•9. Child Pugh C stage liver cirrhosis.
•10. High cardiac output diseases.
+2 more criteria

Locations (1)

Universidad del Rosario

Bogota, Cundinamarca, Colombia

Key Dates

Start Date

August 8, 2020

Primary Completion Date

October 31, 2020

Completion Date

November 15, 2020

Last Updated

November 27, 2020

Enrollment

ACTUAL participants

Conditions

CoronavirusCoronavirus Infection

Interventions

Plasma

DRUG

Standard Therapy

DRUG

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITING

Post COVID-19 Biorepository

NCT04885504

Coronavirus Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Post COVID-19 Biorepository

Capturing MultiORgan Effects of COVID-19

Risk Factors for Community- and Workplace Transmission of COVID-19

ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection

COVID-19 Biorepository