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Convalescent Plasma and Placebo for the Treatment of COVID-19 Severe Pneumonia

NCT04383535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2020-09-30

No results posted yet for this study

Summary

A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.

Conditions

Interventions

OTHER

Convalescent SARS COVID-19 plasma

Convalescent SARS COVID-19 plasma from a pool of 10 donor plasma. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.

OTHER

Placebo

Single infusion of saline solution, in addition to standard care. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Nora A Fuentes, MD · Hospital Privado de la Comunidad de Mar del Plata

  • Florencia Otermin, MD · Hospital Italiano de la Plata

  • Esteban Nannini, MD · Sanatorio Britanico Rosario, pcia Santa Fe

  • Karina Rainiero, MD · Suiza Argentina

  • Erica Miyazaki, MD · Clinica Zabala

  • Gabriela Vidiella, MD · Sanatorio Agote

  • Wanda Cornistein, MD · Austral University, Argentina

  • Leandro Burgos, MD · Hospital Italiano de Buenos Aires

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2020-09-27
Completion
2020-09-27

Countries

  • Argentina

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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 NCT04383535 on ClinicalTrials.gov