NCT04385186

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Blood Center Foundation, Hemolife · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Infections, Coronavirus

Interventions

Type	Name	Description
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
DRUG	Support treatment	Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Timeline

• Start date: 2020-06-20
• Primary completion: 2020-11-30
• Completion: 2020-12-30
• First posted: 2020-05-12
• Last updated: 2020-06-02

Locations

10 sites across 1 country: Colombia