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Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19

NCT04388410 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2020-08-26

No results posted yet for this study

Summary

This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.

Conditions

Interventions

BIOLOGICAL

convalescent plasma

Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.

Sponsors & Collaborators

  • TecSalud Investigación Clínica

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias

    collaborator OTHER_GOV

  • Instituto Nacional de Cardiologia Ignacio Chavez

    collaborator OTHER

  • Hospital General Dr. Manuel Gea González

    collaborator OTHER_GOV

  • Hospital Regional de Alta Especialidad del Bajio

    collaborator OTHER

  • Instituto Nacional de Cancerologia de Mexico

    collaborator OTHER

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Juan G Sierra-Madero, MD · Department of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT04388410 on ClinicalTrials.gov