Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.
The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Universidad del Rosario
Bogota, Cundinamarca, Colombia
Change in Viral Load
Copies of COVID-19 per ml
Time frame: Days 0, 4, 7, 14 and 28
Change in Immunoglobulin M COVID-19 antibodies Titers
Immunoglobulin M COVID-19 antibodies
Time frame: Days 0, 4, 7, 14 and 28
Change in Immunoglobulin G COVID-19 antibodies Titers
Immunoglobulin G COVID-19 antibodies
Time frame: Days 0, 4, 7, 14 and 28
Intensive Care Unit Admission
Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Length of Intensive Care Unit stay
Days of Intensive Care Unit management (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Length of hospital stay (days)
Days of Hospitalization (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Requirement of mechanical ventilation
Proportion of patients with mechanical ventilation (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Duration (days) of mechanical ventilation
Days with mechanical ventilation (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Clinical status assessed according to the World Health Organization guideline
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1\. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)
Time frame: Days 7, 14 and 28
Mortality
Proportión of death patients at days 7, 14 and 28
Time frame: Days 7, 14 and 28