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Convalescent Plasma for Severe COVID-19 Patients

NCT04547660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-02-09

No results posted yet for this study

Summary

Plasma, the supernatant part of blood, contains a variety of different proteins, including immunoglobulins. These proteins, also called antibodies, are directed to previous foreign infecting organisms, such as virus, bacteria or parasites. Patients recovering from SARS-Cov-2 infection may develop protective antibodies which can prevent reinfection with the same agent or similar organisms with shared molecular structures. Those antibodies may be transferred to other patients through collection of such convalescent plasma from recovered donors and its transfusion to ill patients. In this research, the primary hypothesis is that those antibodies can exert passive immunization and help ameliorate symptoms from COVID-19 (Coronavirus Disease 2019), resulting in higher clinical improvement rates at day 28, especially when administered early in the infection course.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Convalescent Plasma

Fresh frozen plasma collected by apheresis from recovered COVID-19 patients added to best supportive care.

OTHER

Best Supportive Care

Any form of ventilatory support, extracorporeal membrane oxygenation, steroids, antibiotics and other supportive measures except for investigational interventions.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

    collaborator OTHER

  • Instituto Cultural Floresta

    collaborator UNKNOWN

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Leo Sekine, PhD · Hospital de Clínicas de Porto Alegre

  • Alexandre P Zavascki, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2021-01-07
Completion
2021-01-07

Countries

  • Brazil

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 NCT04547660 on ClinicalTrials.gov