Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia

PHASE3CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

May 6, 2020

Primary Completion Date

November 26, 2020

Study Completion Date

November 26, 2020

Conditions
COVID-19 Pneumonia
Interventions
DRUG

Plasma from COVID-19 convalescent patient

"Infusion of 400 ml (2 units) of plasma.~Plasma donated from convalescent patients will be extracted in strict compliance with the following criteria:~* History of a clinical event with symptoms attributed to COVID-19 and a positive PCR test for COVID-19~* Further confirmation of a negative PCR test for COVID-19~* In order to be eligible plasma donors must complete at least 14 days after the last negative PCR in the absence of any symptom attributable to COVID-19 infection~* IgG antibodies for COVID-19 must be confirmed POSITIVE when a qualitative assay is being used~* When quantification of IgG antibodies for COVID-19 is available a title \> 1: 640 will be required for inclusion.~* Apheresis will be used as the only method for plasma extraction."

DRUG

Human immunoglobulin

Human immunoglobulin 0.3 gr/kg/day (5 doses)

Trial Locations (1)

20259

Centenario Hospital Miguel Hidalgo, Aguascalientes

All Listed Sponsors
lead

Centenario Hospital Miguel Hidalgo

OTHER

NCT04381858 - Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia | Biotech Hunter | Biotech Hunter