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.
Drug: Inactivated convalescent plasma
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
Other Name: Inactivated convalescent plasma SARS-Cov-2 + Support treatment
Drug: Support treatment
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Other Name: Support treatment under medical decision
Inclusion Criteria:
- Over 18 years old
- Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
- Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized
with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or
severe), Sepsis or Septic shock
- The patient, or his representative, must sign an informed consent
Exclusion Criteria:
- Participate in another clinical trial for CoViD- 19
- History of acute allergic transfusion reactions due to transfusion of blood or other
components, especially plasma components (fresh frozen plasma, cryoprecipitate and
platelets),
- History of allergic reaction due to IgA deficiency
- Allergic reaction to sodium citrate or riboflavin (vitamin B2)
- History of immunosuppression
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, Colombia
Clinica Nuestra
Cali, Valle, Colombia
Clínica Corpas
Bogotá, Colombia
E.S.E Hospital San Rafael Facatativa
Facatativa, Colombia
Clínica la Estancia
Popayán, Colombia
Andrés F Zuluaga, MD, MSc, MeH
3014020291
andres.zuluaga@udea.edu.co
Ana L Muñoz, MSc, PhD
ana.munoz@hemolifeamerica.org
Andrés F Zuluaga, MD, MSc, MeH, Principal Investigator
Universidad de Antioquia