Clinical trial NCT04468009: Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
Official title: Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-Associated Coronavirus
Covid19
SARS-CoV Infection
Keywords: Convalescent plasma
Covid-19 treatment
Transfusion medicine
Lead sponsor: Hospital de Infecciosas Francisco Javier Muniz
Sponsor class: OTHER_GOV
First posted: 2020-07-13
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality at ICU at 30 days
timeFrame: Mortality at 30 days
measure: Mortality at ICU at 90 days
timeFrame: Mortality at 90 days
Secondary outcomes:
measure: SOFA score of study days 1, 3, 5, 7, 14 and 28
timeFrame: Study days 1, 3, 5, 7, 14 and 28
measure: Need for supportive therapy after enrollment
timeFrame: Duration of supportive therapy through study completion, an average of 3 months
measure: Lenght of stay in ICU
timeFrame: Duration of stay in ICU through study completion, an average of 3 months
measure: Lenght of mechanical ventilation
timeFrame: Duration of mechanical ventilation through study completion, an average of 3 months
measure: Lenght of hospitalization
timeFrame: Duration of hospitalization through study completion, an average of 3 months
Other outcomes:
measure: Lenght of hospitalization after ICU discharge
timeFrame: Duration (number of days) of hospitalization through study completion, an average of 3 months
measure: Days without ventilation after enrollment
timeFrame: Days without ventilation through study completion, an average of 3 months
measure: Days without vasopressors after enrollment
timeFrame: Days without vasopressors through study completion, an average of 3 months
measure: Changes in Chest X-ray
timeFrame: Changes in Chest X-ray through study completion, an average of 3 months
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Francisco Javier Muñiz
Study officials:
affiliation: Hospital de Infecciosas Francisco Javier Muniz
name: Carlos A Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
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