COVID-19
Conditions
Keywords
COVID-19, Convalescent plasma, Intensive Care Unit, Critical illness
Brief 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.
Interventions
BIOLOGICALConvalescent plasma
ABO compatible convalescent plasma obtained from from recovered COVID-19 patients
Sponsors
Fundación Cardiovascular de Colombia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental and open-label intervention study. In this study, the application of convalescent plasma is considered as an intervention, but randomization will not be performed by investigators; one arm will be patients who received ABO compatible convalescent plasma and the comparison group will be those patients with intervention indication but without compatible ABO plasma units within the institution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | 30 days | In-hospital mortality after administration of ABO compatible convalescent plasma or indication (but not plasmapheresis for absence of compatible convalescent plasma) for comparison group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of renal replacement therapy | 30 days | Number of patients with medical indication of hemodialysis or peritoneal dialysis for acute renal failure |
| Incidece of adverse events | During tranfusion until 24 hours after. | Number of patients with Alergic reaction, Anaphylaxis, Severe thrombotic events, Transfusion-related acute lung injury (TRALI)\], Transfusion-associated circulatory overload (TACO)\], Antibody-Dependent Enhancement (ADE)\] |
Countries
Colombia
Contacts
Primary ContactNorma Serrano, MD
Backup ContactClaudia Colmenares, MD
Outcome results
None listed