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

Primary Purpose

SARS-Associated Coronavirus, Covid19, SARS-CoV Infection

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Hospital de Infecciosas Francisco Javier Muniz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-Associated Coronavirus focused on measuring Convalescent plasma, Covid-19 treatment, Transfusion medicine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Francisco Javier Muñiz

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

PCC-19

Arm Description

Standard of care for Covid-19

Treatment with convalescent plasma

Outcomes

Primary Outcome Measures

Mortality at ICU at 30 days
Mortality at 30 days of Intensive Care Unit (ICU) admission
Mortality at ICU at 90 days
Mortality at 90 days of ICU admission

Secondary Outcome Measures

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
Need for supportive therapy after enrollment
Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
Lenght of stay in ICU
Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
Lenght of mechanical ventilation
Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
Lenght of hospitalization
Duration (number of days) of hospitalization between hospital admission and final hospital discharge

Full Information

First Posted
July 9, 2020
Last Updated
August 23, 2021
Sponsor
Hospital de Infecciosas Francisco Javier Muniz
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1. Study Identification

Unique Protocol Identification Number
NCT04468009
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Infecciosas Francisco Javier Muniz

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-Associated Coronavirus, Covid19, SARS-CoV Infection
Keywords
Convalescent plasma, Covid-19 treatment, Transfusion medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care for Covid-19
Arm Title
PCC-19
Arm Type
Experimental
Arm Description
Treatment with convalescent plasma
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
Primary Outcome Measure Information:
Title
Mortality at ICU at 30 days
Description
Mortality at 30 days of Intensive Care Unit (ICU) admission
Time Frame
Mortality at 30 days
Title
Mortality at ICU at 90 days
Description
Mortality at 90 days of ICU admission
Time Frame
Mortality at 90 days
Secondary Outcome Measure Information:
Title
SOFA score of study days 1, 3, 5, 7, 14 and 28
Description
Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28
Time Frame
Study days 1, 3, 5, 7, 14 and 28
Title
Need for supportive therapy after enrollment
Description
Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
Time Frame
Duration of supportive therapy through study completion, an average of 3 months
Title
Lenght of stay in ICU
Description
Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
Time Frame
Duration of stay in ICU through study completion, an average of 3 months
Title
Lenght of mechanical ventilation
Description
Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
Time Frame
Duration of mechanical ventilation through study completion, an average of 3 months
Title
Lenght of hospitalization
Description
Duration (number of days) of hospitalization between hospital admission and final hospital discharge
Time Frame
Duration of hospitalization through study completion, an average of 3 months
Other Pre-specified Outcome Measures:
Title
Lenght of hospitalization after ICU discharge
Description
Duration (number of days) of hospitalization after ICU discharge
Time Frame
Duration (number of days) of hospitalization through study completion, an average of 3 months
Title
Days without ventilation after enrollment
Description
Number of days without ventilation after enrollment
Time Frame
Days without ventilation through study completion, an average of 3 months
Title
Days without vasopressors after enrollment
Description
Number of days without vasopressors after enrollment
Time Frame
Days without vasopressors through study completion, an average of 3 months
Title
Changes in Chest X-ray
Description
Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment
Time Frame
Changes in Chest X-ray through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos A Gonzalez, MD
Organizational Affiliation
Hospital de Infecciosas Francisco Javier Muniz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Francisco Javier Muñiz
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
1663
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
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Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma

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