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Biomodulina T - IM- covid-19 - older adultos - Phase IV clinical trial
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Revisions
Comparing two revisions:
27 May 2020 - 4:38pm
by BIOCEN
13 October 2022 - 1:43pm
by BIOCEN
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Changes to
Health condition(s) code
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+
Disease Prevention
+
Aging
+
Coronavirus Infections
+
SARS Virus
+
Coronaviridae Infections
+
Betacoronavirus
Changes to
Health condition keyword
+
Covid-19
+
+
SARS-CoV2
Changes to
Intervention code
-
+
Immunologic Factors
+
Injections, Intramuscular
Changes to
Intervention keyword
+
Biomodulin T
Changes to
Record Verification Date
-
2020
/
05
/
27
+
2022
/
10
/
13
Changes to
Next update date
-
2021
/
05
/
27
+
2023
/
10
/
13
Revision of 13 October 2022 - 1:43pm:
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)
Primary sponsor:
Centro Nacional de Biopreparados (BioCen)
Secondary sponsor:
Not applicable
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:
Liliam
Last name:
Rodriguez Rivera
Medical 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 Revolución
City:
Havana
Country:
Cuba
Zip Code:
10400
Telephone:
+53-78382146
Email address:
liliamrodriguez@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 (32)
Nursing Homes of Pinar del Río (1)
Nursing Homes of Artemisa (5)
Nursing Homes of Mayabeque (6)
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
Health condition(s) code:
Disease Prevention
Aging
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Health condition keyword:
Covid-19
SARS-CoV2
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)
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 (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.
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
Country:
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
Country:
Cuba
Zip Code:
13050, PO Box 6048
Telephone:
+5347682441
Email :
mcarmen.reyes@biocen.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
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
Email:
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:
2022/10/13
Next update date:
2023/10/13
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