Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04468009|
Recruitment Status : Completed
First Posted : July 13, 2020
Last Update Posted : August 25, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|SARS-Associated Coronavirus Covid19 SARS-CoV Infection||Biological: Convalescent plasma||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma|
|Actual Study Start Date :||June 25, 2020|
|Actual Primary Completion Date :||January 19, 2021|
|Actual Study Completion Date :||June 19, 2021|
No Intervention: Standard of care
Standard of care for Covid-19
Treatment with convalescent plasma
Biological: Convalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
- 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
- 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
- Lenght of hospitalization after ICU discharge [ Time Frame: 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 [ Time Frame: Days without ventilation through study completion, an average of 3 months ]Number of days without ventilation after enrollment
- Days without vasopressors after enrollment [ Time Frame: Days without vasopressors through study completion, an average of 3 months ]Number of days without vasopressors after enrollment
- Changes in Chest X-ray [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468009
|Hospital Francisco Javier Muñiz|
|Ciudad Autonoma de Buenos Aire, Argentina, 1663|
|Principal Investigator:||Carlos A Gonzalez, MD||Hospital de Infecciosas Francisco Javier Muniz|
Documents provided by Carlos Alberto Gonzalez, Hospital de Infecciosas Francisco Javier Muniz:
|Responsible Party:||Carlos Alberto Gonzalez, Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz, Hospital de Infecciosas Francisco Javier Muniz|
|Other Study ID Numbers:||
|First Posted:||July 13, 2020 Key Record Dates|
|Last Update Posted:||August 25, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases