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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19, SARS-Associated Coronavirus, SARS-CoV Infection

Intervention / Treatment
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* Biological: Convalescent plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Standard of care for Covid-19 | |
| Experimental: PCC-19<br>Treatment with convalescent plasma | Biological: Convalescent plasma<br>* Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at ICU at 30 days | Mortality at 30 days of Intensive Care Unit (ICU) admission | Mortality at 30 days | 
| Mortality at ICU at 90 days | Mortality at 90 days of ICU admission | Mortality at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Duration of hospitalization through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Convalescent plasma, Covid-19 treatment, Transfusion medicine