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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 19, 2021

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Standard of care
    • Standard of care for Covid-19
  • Experimental: PCC-19
    • Treatment with convalescent plasma

Clinical Trial Outcome Measures

Primary Measures

  • Mortality at ICU at 30 days
    • Time Frame: Mortality at 30 days
    • Mortality at 30 days of Intensive Care Unit (ICU) admission
  • Mortality at ICU at 90 days
    • Time Frame: Mortality at 90 days
    • Mortality at 90 days of ICU admission

Secondary Measures

  • SOFA score of study days 1, 3, 5, 7, 14 and 28
    • Time Frame: Study days 1, 3, 5, 7, 14 and 28
    • Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28
  • Need for supportive therapy after enrollment
    • Time Frame: Duration of supportive therapy through study completion, an average of 3 months
    • Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
  • Lenght of stay in ICU
    • Time Frame: Duration of stay in ICU through study completion, an average of 3 months
    • Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
  • Lenght of mechanical ventilation
    • Time Frame: Duration of mechanical ventilation through study completion, an average of 3 months
    • Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
  • Lenght of hospitalization
    • Time Frame: Duration of hospitalization through study completion, an average of 3 months
    • Duration (number of days) of hospitalization between hospital admission and final hospital discharge

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital de Infecciosas Francisco Javier Muniz
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carlos Alberto Gonzalez, Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz – Hospital de Infecciosas Francisco Javier Muniz
  • Overall Official(s)
    • Carlos A Gonzalez, MD, Principal Investigator, Hospital de Infecciosas Francisco Javier Muniz

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