Trial | NCT04385186  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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 Started
Jun 20
2020
Anticipated
Primary Completion
Nov 30
2020
Anticipated
Study Completion
Dec 30
2020
Anticipated
Last Update
Jun 02
2020

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 names: 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 names: Support treatment under medical decision

Convalescent plasma+Support treatment selected by the hospital Experimental

Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol.

Support treatment selected by the hospital Active Comparator

The best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment.

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
No Results Posted