BIOMODULINA T in a long-lived population at high risk of COVID-19 infection

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:

Safety and effectiveness of BIOMODULINA T in a long-lived population at high risk of COVID-19 infection. Interventional Study (COVID-19)

Secondary indentifying numbers:

GEC2020BMT029

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Liliam

Last name:

Rodriguez Rivera

Medical Specialty :

1st Degree of Integral General Medicine and 1st Degree Specialist in Gerontology and Geriatrics.

Affiliation:

Longevity, Aging and Health Research Center (CITED)

Postal address:

Corner G and 27. Vedado, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382162

Email address:

liliamrodriguez@infomed.sld.cu [1]

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:

Ciego de Avila, Community Polyclinic "Area Norte"

Ciego de Avila, Community Polyclinic "Area Centro"

Ciego de Avila, Community Polyclinic "Area Sur"

Ciego de Avila, Teaching Polyclinic "Belquis Sotomayor"

Ciego de Avila, Community Polyclinic " Ceballos"

Sancti Spíritus, Community Polyclinic "Rudecindo García Rijo"

Santiago de Cuba, Community Polyclinic "28 de septiembre"

Santiago de Cuba, Community Polyclinic "José Martí"

Habana Vieja, Community Polyclinic "Antonio Guiteras"

Habana Vieja, Community Polyclinic "Diego Tamayo"

Habana Vieja, Community Polyclinic "Tomas Romay"

Habana Vieja, Community Polyclinic "Ángel Arturo Aballí"

Habana Vieja, Community Polyclinic "Robert Manuel Zulueta"

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

26/09/2020

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:

COVID-19 prevention

Health condition(s) code:

Disease Prevention

Aging

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Biomodulina T, 1 bulb (3mg / 3mL), once a 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):

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: in each administration of the product up to 30 days after the last dose is administered.

Key secondary outcomes:

1. COVID-19 infection (incidence, occurrence of complications and mortality). Measurement time: 30 days after finished treatment. 2. Appetite improvement (Yes, No). Measurement time: 30 days after finished treatment. 3. Improvement of osteoarticular pain (Yes, No). Measurement time: 30 days after finished treatment. 4. Improvement of sleep disorders (Yes, No). Measurement time: 30 days after finished 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:

75 years

Maximum age:

None

Inclusion criteria:

1. Age 75 years and over. 2. Any sex and skin color. 3. Patients who express their consent in writing, to participate in the study and in the event that 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 intercurrent illnesses including, but not limited to: acute infections with concomitant febrile symptoms, 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:

Interventional

Purpose:

Prevention

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

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:

Liliam

Last Name:

Rodriguez Rivera

Specialty:

1st Degree of Integral General Medicine and 1st Degree Specialist in Gerontology and Geriatrics.

Affiliation:

Longevity, Aging and Health Research Center (CITED)

Postal Address:

Corner G and 27. Vedado, Plaza de la Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382146

Email :

liliamrodriguez@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:

Group of Clinical Trials, Centro Nacional de Biopreparados (BioCen)

Postal Address:

Highway to Beltran Km 1 ½

City:

Mayabeque

País:

Cuba

Zip Code:

13050, P.O. Box 6048

Telephone:

+53-47682441

Email :

mcarmen.reyes@biocen.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

Longevity, Aging and Health Research Center (CITED)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

18/09/2020

Postal address of Ethic Committee :

Street G and 27. Vedado, Plaza de la Revolucion, ZC: 10400 Havana, Cuba

Telephone:

+53-78382146, +53-78382139 ext 501

Correo electrónico:

cited@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

9623

Study completion date:

20/04/2021

Date of available results:

14/05/2021

Date of first publication:

25/06/2021

Results Study

Section to complete the data related to the summarized results.

Results file:

Summary study.pdf [3]

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:

RPCEC00000335

Date of Registration in Primary Registry:

19/09/2020

Record Verification Date:

2022/10/14

Next update date:

2023/10/14

Link to the spanish version:

Click here [4]