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

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ClinicalTrials.gov Identifier: NCT04468009
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Carlos Alberto Gonzalez, Hospital de Infecciosas Francisco Javier Muniz

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.

Condition or disease Intervention/treatment Phase
SARS-Associated Coronavirus Covid19 SARS-CoV Infection Biological: Convalescent plasma Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of care
Standard of care for Covid-19
Experimental: PCC-19
Treatment with convalescent plasma
Biological: Convalescent plasma
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies




Primary Outcome Measures :
  1. Mortality at ICU at 30 days [ Time Frame: Mortality at 30 days ]
    Mortality at 30 days of Intensive Care Unit (ICU) admission

  2. Mortality at ICU at 90 days [ Time Frame: Mortality at 90 days ]
    Mortality at 90 days of ICU admission


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Carlos A Gonzalez, MD +54 9 1157233801 carlosgonzalez@buenosaires.gob.ar

Locations
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Argentina
Hospital Francisco Javier Muñiz Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, 1663
Contact: Carlos A Gonzalez, MD    +54 9 1157233801    carlosgonzalez@buenosaires.gob.ar   
Sponsors and Collaborators
Hospital de Infecciosas Francisco Javier Muniz
Investigators
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Principal Investigator: Carlos A Gonzalez, MD Hospital de Infecciosas Francisco Javier Muniz
  Study Documents (Full-Text)

Documents provided by Carlos Alberto Gonzalez, Hospital de Infecciosas Francisco Javier Muniz:
Informed Consent Form  [PDF] June 16, 2020
Statistical Analysis Plan  [PDF] June 25, 2020

Publications:

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Responsible Party: Carlos Alberto Gonzalez, Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz, Hospital de Infecciosas Francisco Javier Muniz
ClinicalTrials.gov Identifier: NCT04468009    
Other Study ID Numbers: 1725
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Carlos Alberto Gonzalez, Hospital de Infecciosas Francisco Javier Muniz:
Convalescent plasma
Covid-19 treatment
Transfusion medicine
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases