MedTrace Logo

Treatment of Patients With COVID-19 With Convalescent Plasma

NCT04415086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-05-19

No results posted yet for this study

Summary

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study

Conditions

Interventions

BIOLOGICAL

convalescent plasma

The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Sponsors & Collaborators

  • Ministério da Ciência, Tecnologia, Inovações e Comunicações

    collaborator UNKNOWN

  • Faculty of Medicine of Ribeirão Preto (FMRP-USP)

    collaborator OTHER

  • Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas

    collaborator UNKNOWN

  • Hospital Sirio-Libanes

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Grupo Hospitalar Conceição

    collaborator OTHER_GOV

  • Hospital Ernesto Dornelles

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Esper G Kallás, PhD, MD · University of Sao Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-02-15
Completion
2022-02-15

Countries

  • Brazil

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 NCT04415086 on ClinicalTrials.gov