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

NCT ID: NCT04385186

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2020-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Convalescent plasma+Support treatment selected by the hospital

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.

Group Type: EXPERIMENTAL

Inactivated convalescent plasma

Intervention Type: DRUG

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

Support treatment

Intervention Type: DRUG

Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Support treatment selected by the hospital

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.

Group Type: ACTIVE_COMPARATOR

Support treatment

Intervention Type: DRUG

Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Interventions

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

Intervention Type: DRUG

Support treatment

Day 0: Start of support treatment selected by medical staff according to each each institutional protocol

Intervention Type: DRUG

Other Intervention Names

Inactivated convalescent plasma SARS-Cov-2 + Support treatment; Support treatment under medical decision

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Blood Center Foundation, Hemolife

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrés F Zuluaga, MD, MSc, MeH

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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 Department, Colombia

Clinica Nuestra

Cali, Valle del Cauca Department, Colombia

Clínica Corpas

Bogotá, , Colombia

E.S.E Hospital San Rafael Facatativa

Facatativá, , Colombia

Clínica la Estancia

Popayán, , Colombia

Countries

Colombia

Central Contacts

Andrés F Zuluaga, MD, MSc, MeH

Role: CONTACT

andres.zuluaga@udea.edu.co

3014020291

Ana L Muñoz, MSc, PhD

Role: CONTACT

ana.munoz@hemolifeamerica.org

Facility Contacts

Diego Gómez, MD. MSc

Role: primary

diego.gomez@clinicanuestra.com

Andrés F Zuluaga, MD, MSc, MeH

Role: primary

andres.zuluaga@udea.edu.co

3014020291

Ana L Muñoz, MSc, PhD

Role: primary

ana.munoz@hemolifeamerica.org

+573128879089

Diego Gómez, MD, MSc

Role: primary

diego.gomez@clinicanuestra.com

Diego Gómez, MD, Msc

Role: primary

diego.gomez@clinicanuestra.com

Fernando J Charries, MD, MSc

Role: primary

Diego Gómez, MD, MSc

Role: primary

diego.gomez@clinicanuestra.com

References

Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.

Reference Type: BACKGROUND

PMID: 32319102 (View on PubMed)

Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

Reference Type: BACKGROUND

PMID: 32219428 (View on PubMed)

Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.

Reference Type: BACKGROUND

PMID: 32167489 (View on PubMed)

Other Identifiers

CT01

Identifier Type: -

Identifier Source: org_study_id