Status:
COMPLETED
Convalescent Plasma and Placebo for the Treatment of COVID-19 Severe Pneumonia
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
SARS Virus
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ex...
Detailed Description
Introduction The use of convalescent plasma in the treatment of infectious diseases has been empirically performed for more than a century. It is based upon the assumption that providing exogenous ne...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Covid-19 through qualitative polymerase-reverse transcriptase (qRT-PCR -GeneDX Co, Ltd o similar).
- Imagining-diagnosed pneumonia (Rx or CT scan).
- MSOFA score (Modified SOFA) of 2 or more (modified organic failure assessment)
- Informed consent.
Exclusion
- Pregnant women
- Women at reproductive age not willing to avoid unprotected sexual intercourse up to Day 30 after study initiation.
- Women in the breastfeeding period
- Patients receiving experimental treatments under development within 30 days prior to study initiation.
- Patients with a previous history of allergic reactions to blood or blood-components transfusion.
- Diagnosis or clinical suspicion of an alternative microbiological cause for pneumonia besides COVID-19
- Use of systemic corticosteroids within 15 days prior to entering the study.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2020
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT04383535
Start Date
May 15 2020
End Date
September 27 2020
Last Update
September 30 2020
Active Locations (1)
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1
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1181