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

National Blood Center Foundation, Hemolife

Status and phase: Unknown; Phase 2

Conditions: Infections, Coronavirus

Treatments: Drug: Support treatment; Drug: Inactivated convalescent plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04385186

CT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Convalescent plasma+Support treatment selected by the hospital

Experimental group

Description:

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.

Treatment:

Drug: Inactivated convalescent plasma

Drug: Support treatment

Support treatment selected by the hospital

Active Comparator group

Description:

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.

Treatment:

Drug: Support treatment