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Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

NCT04385186 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-02

No results posted yet for this study

Summary

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

Conditions

  • Infections, Coronavirus

Interventions

DRUG

Inactivated convalescent plasma

Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma

DRUG

Support treatment

Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Sponsors & Collaborators

  • National Blood Center Foundation, Hemolife

    lead OTHER

Principal Investigators

  • Andrés F Zuluaga, MD, MSc, MeH · Universidad de Antioquia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2020-11-30
Completion
2020-12-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385186 on ClinicalTrials.gov