Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.
This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Clínica Antioquía
Medellín, Antioquía, Colombia
Clínica Sagrado Corazón
Medellín, Antioquía, Colombia
IPS Universitaria
Medellín, Antioquía, Colombia
Universidad de Antioquía
Medellín, Antioquía, Colombia
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
Bogotá, Cundinamarca, Colombia
Clínica Rosales
Pereira, Risaralda Department, Colombia
Clinica Nuestra
Cali, Valle del Cauca Department, Colombia
Clínica Corpas
Bogotá, Colombia
E.S.E Hospital San Rafael Facatativa
Facatativá, Colombia
Clínica la Estancia
Popayán, Colombia
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
Time frame: Over a period of 28 days
Clinical evolution
Number of Participants with resolution of fever (\<38ºC temperature)
Time frame: Over a period of 28 days
Clinical evolution by seven-parameter ordinal scale
The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death
Time frame: 3, 7, 14 and 28 days
Multi-organ failure progression
Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness
Time frame: 3, 7, 14 and 28 days
Change in hemoglobin concentration
Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in blood cell count
Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in serum creatinine level
Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in aspartate aminotransferase level
Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in alanin aminotransferase level
Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in bilirubin level
Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in lactate dehydrogenase level
Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in creatine kinase level
Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in creatine kinase MB level
Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in C reactive protein concentration
Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
Time frame: 3, 7, 14 and 28 days
Change in D Dimer concentration
Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in Procalcitonin concentration
Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Change in IL6 level
Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
Time frame: 3, 7, 14 and 28 days
Radiography imaging
Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Time frame: Over a period of 60 days
Tomography imaging
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Time frame: Over a period of 60 days
Assessment of oxygenation
Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
Time frame: 3, 7, 14 and 28 days
Viral Load
Viral Load Quantification
Time frame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Antibody titer
Neutralizing antibody anti SARS-CoV-2 titer evolution
Time frame: Day 0, Day 3 and Day 7
Oxygen-free days through Day 60
Number of days without use of Oxygen
Time frame: Until hospital discharge or a maximum of 60 days whichever comes first
Mechanical ventilation-free days through Day 28
Number of days without use of mechanical ventilation
Time frame: Until hospital discharge or a maximum of 28 days whichever comes first
Intensive Care Unit (ICU)-free days through Day 28
Time outside of ICU, in days
Time frame: Until hospital discharge or a maximum of 28 days whichever comes first
Hospital-free days through Day 60
Time outside of the hospital, in days
Time frame: Until hospital discharge or a maximum of 60 days whichever comes first
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