Exploratory study of BMT EV to stimulate immune response in patients with CKD-5 on iterated hemodialysis

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect and safety of BIOMODULIN T® for the stimulation of the immune response in patients with Stage 5 Chronic Kidney Disease under an iterated hemodialysis regimen. Exploratory study. (COVID-19)

Secondary indentifying numbers:

GEC2020BMT027

Issuing authority of the secondary identifying numbers:

Centro Nacional de Biopreparados (BioCen)

Source(s) of monetary or material support:

Centro Nacional de Biopreparados (BioCen), Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

25/06/2020

Reference number:

-

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Francisco

Last name:

Perez- Oliva Diaz

Medical Specialty :

Doctor of Medical Sciences. MSc. Epidemiology and specialist in 1st and 2nd grade of Nephrology, Professor.

Affiliation:

National Institute of Nephrology “Dr. Abelardo Buch Lopez”

Postal address:

Avenue 26 y Rancho Boyeros. Cerro

City:

La Habana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78816442

Email address:

scnefro@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, "Hermanos Ameijeiras" Surgical Clinical Hospital, Martha Veronica Gonzalez Alvarez, MD. MSc. Atherosclerosis research. 1st and 2nd grade specialist in Nephrology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/07/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Immune response in patients with CKD-5 on an iterated hemodialysis regimen

Health condition(s) code:

Kidney Failure, Chronic

Renal Insufficiency, Chronic

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Virus Diseases

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group 1 Experimental: Biomodulin T, 1 bulb (3mg / 3mL), twice a week, intramuscularly (IM) for 6 weeks Group 2 Control: (Biomodulin T will not be administered)

Intervention code:

Immunologic Factors

Injections Intramuscular

Intervention keyword:

Biomodulin T

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Hemogram (Hemoglobin, Hematocrit, Leukogram with differential and Platelets). Measurement time: at baseline and, 8 weeks after randomization Lymphocyte subpopulations (CD3+/CD4+, CD3+/CD8+, CD19+ and, CD3-/CD56 +). Measurement time: at baseline and, 8 weeks after randomization Igs Quantification (IgA, IgM and, IgG). Measurement time: at baseline and, 8 weeks after randomization Complement Quantification (C3 and C4). Measurement time: at baseline and, 8 weeks after randomization

Key secondary outcomes:

Clinical response variables 1. COVID-19 infection (occurrence of complications and mortality). Measurement time: at baseline and, 8 weeks after randomization. 2. Infections (Number (0 to infinity), Type (depending on the organ or system affected), Need for antibiotic treatment (Yes or No), Etiology (Bacterial, Viral, Fungal or Parasitic), Route of administration of antibiotic treatment (Oral and / o Parenteral), Need for hospital admission (Yes or No), Mortality due to infection (Yes or No), Acute phase reactants (C-Reactive Protein and Ferritin)). Measurement time: at baseline and, 8 weeks after randomization. 3. Adverse Events-AE (AE will be classified according to Type (name of AE), Location (Local or Systemic), Time of appearance (immediate or late), Duration (Less than one day or Greater than one day), Previous knowledge (expected or unexpected), Intensity ( Mild, Moderate, or Severe), Consequence (Serious or Not Serious), Causation (Very Probable / Safe, Probable, Possible, Improbable, Unrelated, Not Evaluable / Not Classifiable), Outcome of Adverse Event (Recovered, Not Recovered, Recovered with sequelae, Death or Unknown) and attitude towards the study treatment (Continuation or definitive interruption). Measurement time: during all administrations of the product and, 8 weeks after randomization.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 años

Maximum age:

None

Inclusion criteria:

1. Patients who meet the diagnostic criteria 2. Any gender and skin color and age over 18 years. 3. Patients who express their written consent, to participate in the study

Exclusion criteria:

1. Patients who have received treatment with BIOMODULINA T® in the previous three months. 2. Patients with known hypersensitivity to any component of the formulation. 3. Patients with acute allergic states or history of severe allergic reactions. 4. Patients with primary or secondary glomerulopathies. 5. Patients with immunosuppressive treatment. 6. Patients with hemoglobin less than or equal to 99 g / L 7. Patients with uncontrolled breakthrough diseases including, but not limited to: acute infections with concomitant febrile illness, symptomatic congestive heart failure, unstable angina pectoris. 8. Patients with a previous diagnosis of COVID-19 infection.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Jorge

Middle Name:

Francisco

Last Name:

Perez- Oliva Díaz

Specialty:

Doctor of Medical Sciences. MSc. Epidemiology and specialist in 1st and 2nd grade of Nephrology, Professor.

Affiliation:

National Institute of Nephrology “Dr. Abelardo Buch Lopez”

Postal Address:

Avenue 26 y Rancho Boyeros, Cerro.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78816442

Email :

scnefro@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mary

Middle Name:

Carmen

Last Name:

Reyes Zamora

Specialty:

First Degree Specialist in Immunology, Master in Clinical Trials

Affiliation:

Centro Nacional de Biopreparados (BioCen)

Postal Address:

Beltran Road, Km 1 1/2, Bejucal.

City:

Mayabeque

País:

Cuba

Zip Code:

13050, PO Box 6048

Telephone:

+53-47682441

Email :

mcarmen.reyes@biocen.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Institute of Nephrology “Dr. Abelardo Buch Lopez”

"Hermanos Ameijeiras" Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/06/2020

17/06/2020

Postal address of Ethic Committee :

Avenida 26 y Rancho Boyeros. CP. 10 600. Cerro. La Habana. Cuba

San Lazaro 701 esq. Belascoain, Centro Habana, La Habana, Cuba. CP 10400

Telephone:

+53-7881 2413, +53-78854558, +53-78816442

+53-78761000

Correo electrónico:

insnef@infomed.sld.cu

nefro@hha.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

20

Study completion date:

18/09/2020

Date of available results:

19/10/2020

Date of first publication:

15/01/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000316

Date of Registration in Primary Registry:

28/05/2020

Record Verification Date:

2022/10/13

Next update date:

2023/10/13

Link to the spanish version:

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Exploratory study of BMT EV to stimulate immune response in patients with CKD-5 on iterated hemodialysis

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