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Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia

NCT04381858 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-11-30

No results posted yet for this study

Summary

Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives.

Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection.

Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin.

Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.

Conditions

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)

Sponsors & Collaborators

  • Centenario Hospital Miguel Hidalgo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2020-11-26
Completion
2020-11-26

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04381858 on ClinicalTrials.gov