Biomodulina T - IM- covid-19 - older adultos - Phase IV clinical trial | Registro Público Cubano de Ensayos Clínicos

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Biomodulina T - IM- covid-19 - older adultos - Phase IV clinical trial

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 safety and efficacy of BIOMODULINA T® for the prevention of infections, including COVID-19, in older adults in Cuba. Phase IV clinical trial (COVID-19)

Acronym of Scientific Title:

GEC2020BMT024

Secondary indentifying numbers:

GEC2020BMT024

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:

Trials notification

Regulatory instance:

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

Notification date :

01/04/2020

Reference number:

In process

Principal investigator

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

First name:

1- Liliam; 2- Consuelo

Last name:

1- Rodriguez Rivera; 2- Macias Abraham

Medical Specialty :

1- Specialist of First Degree in Gerontology and Geriatrics; 2- Specialist of 2nd. Degree in Immunology

Affiliation:

1- Research Center on Longevity, Aging and Health (CITED; 2-Institute of Hematology and Immunology (IHI)

Postal address:

1- Corner G and 27. Vedado, Plaza de la Revolución; 2- 19th between 8 and 10, Vedado, Plaza de la Revolución

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382146

+53-78320485

Email address:

liliamrodriguez@infomed.sld.cu

cmabraham@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:

Nursing Homes of Havana (33)

Nursing Homes of Pinar del Río (1)

Nursing Homes of Artemisa (5)

Nursing Homes of Mayabeque (7)

Nursing Homes of Matanzas (10)

Nursing Homes of Villa Clara (16)

Nursing Homes of Cienfuegos (5)

Nursing Homes of Sancti Spiritus (8)

Nursing Homes of Ciego de Avila (8)

Nursing Homes of Camaguey (15)

Nursing Homes of Las Tunas (9)

Nursing Homes of Holguin (8)

Nursing Homes of Granma (8)

Nursing Homes of Santiago de Cuba (13)

Nursing Homes of Guantanamo (5)

Nursing Homes of Isla de la Juventud (2)

Traveler isolation centers (13)

Psychopedagogical care centers

Non-hospitalized older adults from BioCen, OSDE BioCubaFarma, OC of MINSAP and other sites

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

03/04/2020

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:

Prevention of infections, including covid-19

Intervention(s):

Group I: Biomodulin T, 1 bulb twice a week by intramuscular route (IM) for 6 weeks. The treatment will apply to the patients with the highest risk of morbidity and mortality due to chronic cardiovascular diseases, severe asthma, chronic obstructive pulmonary disease, diabetes mellitus, hypertension or clinical evidence of immunosuppression Group II: Biomodulin T, 1 bulb a week by intramuscular route (IM) for 6 weeks. The treatment will apply to the patients with lowest risk (not meet the criteria of group 1)

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):

Adverse Events-AE (The AE will be classified according to Type, Location, Time of appearance, Duration, Previous knowledge, Intensity, Consequence, Causality, Result and, attitude regarding the study treatment). Measurement time: In each administration of the product and, 30 days after the last dose of the product was administered.

Key secondary outcomes:

A) Clinical response variables 1. COVID-19 infection (incidence, occurrence of complications and mortality) Measurement time: one month after the end of treatment; 6 months and, one year after starting treatment. 2. Infections: Number, Type (depending on the organ or system affected), Need for antibiotic treatment, Route of administration of antibiotic treatment, Need for hospital admission, Mortality. Measurement time: initial evaluation (up to 1 year before), in the evaluation one month after the treatment; 6 months and one year after starting treatment. B) Immune response variables. These determinations will be made to 30 internal patients of the "Alfredo Gomez Gendra" Nursing Home. 1. Hemogram (Hemoglobin, Hematocrit and Leukogram with differential). Measurement time: initial evaluation, one week after the end of treatment, and 6 months after starting treatment. 2. Immunological studies of lymphocyte subpopulations (CD3 + / CD4 +, CD3 + / CD8 +, CD19 +, CD3-CD56 +). Measurement time: initial evaluation, one week after the end of treatment, and 6 months after starting treatment. 3. Quantification of Igs (IgA, IgM and IgG). Measurement time: initial evaluation, one week after the end of treatment, and 6 months after starting treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

60 years

Maximum age:

none

Inclusion criteria:

1. Age 60 years and over. 2. Any sex and skin color. 3. Patients who express their consent in writing, to participate in the study and in case major cognitive impairment is present, be signed by a family member, tutor or caregiver.

Exclusion criteria:

1. Patients who have received treatment with BIOMODULINA T® in the previous two 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 uncontrolled breakthrough diseases including, but not limited to: acute infections with concomitant febrile illness, symptomatic congestive heart failure, unstable angina pectoris.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Observational

Purpose:

Prevention

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

4

Target sample size:

Inclusion at 2 months

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:

Lilliams

Last Name:

Rodriguez Rivera

Specialty:

Specialist of First Degree in Gerontology and Geriatrics

Affiliation:

Research Center on Longevity, Aging and Health (CITED)

Postal Address:

Corner G and 27. Vedado. Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+5378382146

Email :

liliamrodriguez@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

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

13050, PO Box 6048

Telephone:

+5347682441

Email :

mcarmen.reyes@biocen.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Research Center on Longevity, Aging and Health (CITED)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/03/2020

Postal address of Ethic Committee :

Esquina G y 27. Vedado. Plaza de la Revolucion, Havana, Cuba CP:10400

Telephone:

+5378382146, +5378382139 ext 501

Correo electrónico:

cited@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/06/2021

Date of available results:

30/07/2021

Date of first publication:

30/08/2021

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:

RPCEC00000310

Date of Registration in Primary Registry:

05/05/2020

Record Verification Date:

2020/05/12

Next update date:

2021/05/12

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