Biomodulina T - IM - covid-19

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 efficacy and safety of a new BIOMODULINA T® dosage scheme for the prevention of infections, including COVID-19, in older adults in Cuba. Confirmatory study (COVID-19)

Secondary indentifying numbers:

GEC2020BMT025

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 the Quality of Drugs(CECMED)

Authorization date :

17/11/2020

Reference number:

498/05.007.20BNV

Principal investigator

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

First name:

Luis; Consuelo

Midle name:

Felipe

Last name:

Heredia Guerra; Macias Abraham

Medical Specialty :

2nd Degree Specialist in Gerontology and Geriatrics. Assistant Researcher. Assistant Professor. Head of the National Gerontology and Geriatrics Group. Deputy Director of CITED Medical Assistance; Medical specialist of 2nd degree of Immunology. Director of the IHI. Head of the National Immunology Group

Affiliation:

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

Postal address:

Corner G and 27, Vedado, Plaza de la Revolucion.; 19 between 8 and 10., Vedado, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382162

+53-78320485

Email address:

viceamcited@infomed.sld.cu [1]

cmabraham@infomed.sld.cu [2]

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:

Mayabeque , Nursing Home "Santa Susana" Bejucal municipality

Havana, Nursing Home "Alfredo Gómez Gendra" Centro Habana municipality

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

13/04/2020

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

Health condition(s) code:

Infections

Disease Prevention

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

SARS Virus

Betacoronavirus

Respiratory Tract Infections

Aging

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Biomodulin T, 1 bulb (3mg/3mL), 2 times per week, intramuscularly (IM) for 6 weeks.

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):

Respiratory infections (Number (0 to infinity), Type (- High Respiratory, including a common cold, Sinusitis, Otitis, Laryngitis or Pharyngotonsillitis; - Low Respiratory such as Bronchitis, Bronchopneumonia), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for antibiotic treatment (Yes or No), Route of administration of antibiotic treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No). Measurement time: In the initial evaluation, in the monthly evaluation and final evaluation (6 weeks)

Key secondary outcomes:

1. Infections from other systems (Number (0 to infinity), Type (Digestive, Skin and soft tissues, Genitourinary, CNS, SOMA, Generalized, Other), Etiology (Bacterial, Viral, Fungal or Parasitic), Need for antibiotic treatment (Yes or No), Route of administration of antibiotic treatment (Oral or Parenteral), Need for hospital admission (Yes or No) and Mortality due to infection (Yes or No). Measurement time: In the initial evaluation, in the monthly evaluation, and final evaluation (6 weeks). 2. COVID-19 infection (Occurrence (Yes or No), Complications (Yes or No) and Mortality (Yes or No)). Measurement time: In the evaluation per month and final evaluation (6 weeks). 3. Immunological Evaluation that will consist of Hemogram (Hemoglobin, Hematocrit, Leukogram with differential), Measurement time: In the initial and final evaluation; Lymphocyte subpopulations (CD3 + / CD4 +, CD3 + / CD8 +, CD19 + and CD3-CD56 +) and Igs Quantification (IgA, IgM and IgG) the immunological study will be measured: In the initial evaluation, one week after completing the treatment and final evaluation (6 weeks). 4. Adverse events-AE (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 / certain, Probable, Possible, Improbable, Not related, Not evaluable / not classifiable), Outcome of AD (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. In the evaluation per month, and final evaluation. In a sample of 30 randomly selected patients, from the “Alfredo Gomez Gendra” Nursing Home, it will be where the immunological parameters will be evaluated, before and after treatment, and their association with clinical variables will be evaluated by statistical methods. Carrying out the immunological study constitutes a research project led by the IHI.

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. Patients who meet the diagnostic criteria 2. Any sex and skin color aged 60 years and over. 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

160

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:

Luis

Middle Name:

Felipe

Last Name:

Heredia Guerra

Specialty:

2nd Degree Specialist in Gerontology and Geriatrics. Assistant Researcher. Assistant Professor. Head of the National Gerontology and Geriatrics Group. Deputy Director of CITED Medical Assistance

Affiliation:

Research Center on Longevity, Aging and Health (CITED)

Postal Address:

Corner G and 27, Vedado, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382162

Email :

viceamcited@infomed.sld.cu [1]

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:

Clinical Trials Group, Centro Nacional de Biopreparados (BioCen)

Postal Address:

Beltran Highway Km 1 ½, Bejucal

City:

Mayabeque

Country:

Cuba

Zip Code:

13050, PO Box 6048

Telephone:

+53-47682441

Email :

mcarmen.reyes@biocen.cu [3]

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 :

Corner G and 27, Vedado, Plaza de la Revolucion. CP:10400, Havana, Cuba

Telephone:

+537-8382146, +53-78382139 ext 501

Email:

cited@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

160

Study completion date:

18/12/2020

Date of available results:

04/09/2021

Date of first publication:

01/09/2021

Results Study

Section to complete the data related to the summarized results.

Results file:

Summary study.pdf [4]

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:

RPCEC00000319

Date of Registration in Primary Registry:

29/05/2020

Record Verification Date:

2022/10/14

Next update date:

2023/10/14

Link to the spanish version:

Click here [5]

Biomodulina T - IM - covid-19 - older adult