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Completed

NCT Number: NCT04468009

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

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.

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Key information

Conditions

SARS-Associated Coronavirus COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV Infection Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Francisco Javier Muñiz

Ciudad Autonoma de Buenos Aire, 1663, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Convalescent Plasma

Biological

Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital de Infecciosas Francisco Javier Muniz

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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