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

Hospital de Infecciosas Francisco Javier Muniz

Status and phase: Completed; Phase 2

Conditions: SARS-CoV Infection; SARS-Associated Coronavirus; Covid19

Treatments: Biological: Convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04468009

1725

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

134 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Standard of care for Covid-19

PCC-19

Experimental group

Description:

Treatment with convalescent plasma

Treatment:

Biological: Convalescent plasma