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:
Secondary indentifying numbers:
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:
Regulatory instance:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
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
Telephone:
+53-78382146
+53-78320485
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:
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
Date of first enrollment:
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: Biomodulina 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: Biomodulina 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.
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.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Non-randomized controlled trial
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
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
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.
Specialty:
First Degree Specialist in Immunology, Master in Clinical Trials
Affiliation:
Centro Nacional de Biopreparados (BioCen)
Data Sharing Section to complete the data related to the data sharing plan.
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 date of Ethic Committee:
Postal address of Ethic Committee :
Esquina G y 27. Vedado. Plaza de la Revolucion, Havana, Cuba CP:10400
Telephone:
+5378382146, +5378382139 ext 501
About study completion Section to complete the data related to the study completion.
Date of available results:
Date of first publication:
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).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
