Viewing Study NCT04480632



Ignite Creation Date: 2024-05-06 @ 2:58 PM
Last Modification Date: 2024-10-26 @ 1:40 PM
Study NCT ID: NCT04480632
Status: UNKNOWN
Last Update Posted: 2020-07-22
First Post: 2020-07-17

Brief Title: Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis
Sponsor: Fundación Cardiovascular de Colombia
Organization: Fundación Cardiovascular de Colombia

Study Overview

Official Title: Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis Plasmaféresis terapéutica en Pacientes Adultos críticamente Enfermos Con diagnóstico Confirmado de COVID-19
Status: UNKNOWN
Status Verified Date: 2020-07
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PLASMA
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None