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

NCT04468009 | Completed Phase 2 DMC

• 1 other identifier: 1725
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-Associated Coronavirus; Covid19; SARS-CoV Infection

Keywords

Convalescent plasma; Covid-19 treatment; Transfusion medicine

Outcome Measures

Primary Outcomes (2)

• Mortality at ICU at 30 days

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

  Mortality at 30 days

• Mortality at ICU at 90 days

  Mortality at 90 days of ICU admission

  Mortality at 90 days

Secondary Outcomes (5)

• SOFA score 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

  Duration of supportive therapy through study completion, an average of 3 months

• Lenght of stay in ICU

  Duration of stay in ICU through study completion, an average of 3 months

• Lenght of mechanical ventilation

  Duration of mechanical ventilation through study completion, an average of 3 months

• Lenght of hospitalization

  Duration of hospitalization through study completion, an average of 3 months

Other Outcomes (4)

• Lenght of hospitalization after ICU discharge

  Duration (number of days) of hospitalization through study completion, an average of 3 months

• Days without ventilation after enrollment

  Days without ventilation through study completion, an average of 3 months

• Days without vasopressors after enrollment

  Days without vasopressors through study completion, an average of 3 months

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care for Covid-19

PCC-19

EXPERIMENTAL

Treatment with convalescent plasma

Biological: Convalescent plasma

Interventions

Convalescent plasma BIOLOGICAL

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

PCC-19

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Infecciosas Francisco Javier Muniz: lead

Study Sites (1)

Hospital Francisco Javier Muñiz

Ciudad Autonoma de Buenos Aire, 1663, Argentina

Location

Related Publications (25)

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MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Carlos A Gonzalez, MD

  Hospital de Infecciosas Francisco Javier Muniz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: June 25, 2020
• Primary Completion: January 19, 2021
• Study Completion: June 19, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)