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

August 23, 2021 updated by: Carlos Alberto Gonzalez, Hospital de Infecciosas Francisco Javier Muniz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aire, Argentina, 1663
        • Hospital Francisco Javier Muñiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at ICU at 30 days
Time Frame: Mortality at 30 days
Mortality at 30 days of Intensive Care Unit (ICU) admission
Mortality at 30 days
Mortality at ICU at 90 days
Time Frame: Mortality at 90 days
Mortality at 90 days of ICU admission
Mortality at 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Duration of supportive therapy through study completion, an average of 3 months
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
Duration of stay in ICU through study completion, an average of 3 months
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
Duration of mechanical ventilation through study completion, an average of 3 months
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
Duration of hospitalization through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Duration (number of days) of hospitalization through study completion, an average of 3 months
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 ventilation through study completion, an average of 3 months
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
Days without vasopressors through study completion, an average of 3 months
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
Changes in Chest X-ray through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Infecciosas Francisco Javier Muniz

Investigators

  • Principal Investigator: Carlos A Gonzalez, MD, Hospital de Infecciosas Francisco Javier Muñiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

June 19, 2021

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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