CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 333 enrolled
Drug / intervention
Convalescent SARS COVID-19 plasma +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04383535
NCT04383535N/ACompleted

Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria

Hospital Italiano de Buenos Aires·interventional·Posted May 12, 2020·Updated Sep 30, 2020

In Brief

A clinical study evaluating Convalescent SARS COVID-19 plasma and Placebo for SARS Virus and 2 related conditions. Completed, enrolled 333 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 12, 2020
Enrollment StartMay 15, 2020
Primary CompletionSep 27, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 years ago

Interventions

Convalescent SARS COVID-19 plasmaother

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.

Placeboother

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.