Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

Hospital de Infecciosas Francisco Javier Muniz134 enrolled

Overview

This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.

This study aims to use convalescent plasma as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19 patients on mechanical ventilation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

SARS-Associated Coronavirus Covid19 SARS-CoV Infection

Interventions

Convalescent plasmaBIOLOGICAL

Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 years or more. * Patient with Covid-19 confirmed with nuclear acid testing * Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-19. * Diagnosed with acute respiratory distress syndrome. * Informed consent. Exclusion Criteria: * No consent. * Symptoms for a period longer than 20 days. * Not detectable by acid nuclear testing within 48 hours prior to elegibility. * Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk. * History of severe adverse events or anaphylaxis to plasma components

Locations (1)

Hospital Francisco Javier Muñiz

Ciudad Autonoma de Buenos Aire, Argentina

Outcomes

Primary Outcomes

Mortality at ICU at 30 days

Mortality at 30 days of Intensive Care Unit (ICU) admission

Time frame: Mortality at 30 days

Mortality at ICU at 90 days

Mortality at 90 days of ICU admission

Time frame: Mortality at 90 days

Secondary Outcomes

SOFA score of study days 1, 3, 5, 7, 14 and 28

Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28

Time frame: Study days 1, 3, 5, 7, 14 and 28

Need for supportive therapy after enrollment

Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment

Time frame: Duration of supportive therapy through study completion, an average of 3 months

Lenght of stay in ICU

Duration (number of days) of stay in ICU between ICU admission and ICU final discharge

Time frame: Duration of stay in ICU through study completion, an average of 3 months

Lenght of mechanical ventilation

Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation

Time frame: Duration of mechanical ventilation through study completion, an average of 3 months

Lenght of hospitalization

Duration (number of days) of hospitalization between hospital admission and final hospital discharge

Time frame: Duration of hospitalization through study completion, an average of 3 months

Data from ClinicalTrials.gov

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