Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial

Summary

The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19) a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and substantial mortality. So it is of utmost importance to find new treatments. Various therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was used as an empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was effective.

For this study, plasma from convalescent donors will be collected from those donors who have recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive 1 to 3 convalescent plasma transfusions, depending on the response to treatment.

The expected results are: normal body temperature, decrease in viral load or negative between 10-12 days after transfusion of convalescent plasma, which does not progress to ARDS, extubation of mechanical ventilation within two weeks of treatment, recovery of patient.

Conditions

• SARS Pneumonia

Interventions

BIOLOGICAL

Convalescent Plasma of patients with COVID-19

Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.

OTHER

placebo (hartmann plus albumine)

use of albumin 20% in 250cc of Hartmann solution

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval

  collaborator OTHER_GOV

• National Institute of Pediatrics, Mexico

  collaborator OTHER_GOV

• Instituto Nacional de Enfermedades Respiratorias

  collaborator OTHER_GOV

• Grupo Mexicano para el Estudio de la Medicina Intensiva

  lead OTHER

Principal Investigators

• ORLANDO CARILLO-TORRES, PHD · Hospital General de Mexico Dr. Eduardo Liceaga

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-20

Primary Completion

2020-11-20

Completion

2020-12-10

Countries

• Mexico

Study Locations