Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

• Status: Not yet recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Blood Center Foundation, Hemolife
• Collaborator: Universidad de Antioquia

Criteria

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