Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis (PLASMA)

Fundación Cardiovascular de Colombia

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Biological: Convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04480632

CEI-2020-01200

Details and patient eligibility

About

Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.

Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).

Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.

Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range: Over 18 years old
• Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:
• Respiratory failure receiving ventilatory support and high parameters
• Severe pneumonia with rapid progression
• Ability to sign informed consent

Exclusion criteria

• Pregnant women
• Contraindication of plasma administration due to history of anaphylaxis during transfusions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

ABO compatible convalescent plasma

Experimental group

Description:

A 500 ml dose of convalescent plasma (from a single donor or two 250 ml units from one or two donations) collected by apheresis will be administered. In case of plasma storage, plasma unit will be thawed following parameters of blood bank. Administration will take place slowly and over the course of four hours. When two 250 ml units are administered, second unit must be administered after the first unit in a period not exceeding 12 hours.

Treatment:

Biological: Convalescent plasma

Usual care

No Intervention group

Description:

Usual medical care for critically ill patients at ICU