CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19

Summary

The present study will try to respond first in an initial phase, what is the minimum effective dose necessary of convalescent plasma for getting better in severly ill (not intubated) or very severely ill (intubated) patients.

Once the dose will be determined by each type of patient group (severely ill vs. very severely ill) has been determined, phase 2 of the study will begin, where the safety and efficacy of the use of plasma will be evaluated based on clinical, imaging and laboratory criteria.

So, our hypotheses are:

1. Is there a minimum effective dose to treat seriously ill patients with convalescent plasma with COVID-19?
2. the plasma dose with the minimum effective effect will improve the clinical, laboratory and clearance conditions of the presence of the virus in the severely ill patient?

Conditions

• COVID-19
• SARS-CoV 2
• Convalescence
• Plasma
• Doses

Interventions

BIOLOGICAL

convalescent plasma

In phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case. In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated.

Sponsors & Collaborators

• SECRETARIA DE SALUD DEL ESTADO DE SONORA

  collaborator UNKNOWN

• CENTRO ESTATAL DE LA TRANSFUSION SANGUINEA

  collaborator UNKNOWN

• HOSPITAL CENTRAL NACIONAL PEMEX NORTE

  collaborator UNKNOWN

• HOSPITAL DE ZONA No. 2 IMSS

  collaborator UNKNOWN

• HOSPITAL DE ZONA No.14 IMSS

  collaborator UNKNOWN

• HOSPITAL GENERAL DEL ESTADO DE SONORA

  collaborator UNKNOWN

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  lead OTHER_GOV

Principal Investigators

• Luis M Villela, MD · ISSSTESON

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-20

Primary Completion

2020-11-30

Completion

2020-12-31

Countries

• Mexico

Study Locations