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

NCT04480632 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-07-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Convalescent plasma

ABO compatible convalescent plasma obtained from from recovered COVID-19 patients

Sponsors & Collaborators

  • Fundación Cardiovascular de Colombia

    lead OTHER

Principal Investigators

  • Norma Serrano, MD · Research, development and innovation director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-31
Completion
2022-08-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480632 on ClinicalTrials.gov