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

Phase 2

Completed

• Conditions: SARS-Associated Coronavirus; Covid19; SARS-CoV Infection
• Interventions: Biological: Convalescent plasma

• Registration Number: NCT04468009
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-13
• Primary Completion: 2021-01-19
• Study Completion: 2021-06-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PCC-19	Convalescent plasma	Treatment with convalescent plasma

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SOFA score of study days 1, 3, 5, 7, 14 and 28	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 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
Lenght of stay in ICU	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
Lenght of mechanical ventilation	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
Lenght of hospitalization	Duration of hospitalization through study completion, an average of 3 months	Duration (number of days) of hospitalization between hospital admission and final hospital discharge

Trial Locations

Locations (1)

Hospital Francisco Javier Muñiz; 🇦🇷 Ciudad Autonoma de Buenos Aire, Argentina