Covid19, SARS-Associated Coronavirus, SARS-CoV Infection
Conditions
Keywords
Convalescent plasma, Covid-19 treatment, Transfusion medicine
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.
Interventions
BIOLOGICALConvalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
Sponsors
Hospital de Infecciosas Francisco Javier Muniz
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at ICU at 30 days | Mortality at 30 days | Mortality at 30 days of Intensive Care Unit (ICU) admission |
| Mortality at ICU at 90 days | Mortality at 90 days | Mortality at 90 days of ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for supportive therapy after enrollment | 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 |
| SOFA score of study days 1, 3, 5, 7, 14 and 28 | Study days 1, 3, 5, 7, 14 and 28 | Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28 |
| Lenght of stay in ICU | 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 | 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 | Duration of hospitalization through study completion, an average of 3 months | Duration (number of days) of hospitalization between hospital admission and final hospital discharge |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Chest X-ray | Changes in Chest X-ray through study completion, an average of 3 months | Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment |
| Days without vasopressors after enrollment | Days without vasopressors through study completion, an average of 3 months | Number of days without vasopressors after enrollment |
| Lenght of hospitalization after ICU discharge | Duration (number of days) of hospitalization through study completion, an average of 3 months | Duration (number of days) of hospitalization after ICU discharge |
| Days without ventilation after enrollment | Days without ventilation through study completion, an average of 3 months | Number of days without ventilation after enrollment |
Countries
Argentina
Outcome results
None listed