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BIOMODULINA T in a long-lived population at high risk of COVID-19 infection
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19 Septiembre 2020 - 11:05pm
por Gladys
14 Octubre 2022 - 9:28am
por BIOCEN
Cambios a
Clinical sites
Ciego de Avila, Teaching Polyclinic "Belquis Sotomayor"
Ciego de Avila, Teaching Polyclinic "Belquis Sotomayor"
Ciego de Avila, Community Polyclinic " Ceballos"
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"
Cambios a
Recruitment status
-
Pending
+
Recruiting
Cambios a
Date of first enrollment
-
2020-09-
21
00:00:00
+
2020-09-
26
00:00:00
Cambios a
Postal address of Ethic Committee
-
Corner
G and 27. Vedado, Plaza de la Revolucion, ZC: 10400 Havana, Cuba
+
Street
G and 27. Vedado, Plaza de la Revolucion, ZC: 10400 Havana, Cuba
Cambios a
Final enrolment number
-
+
9623
Cambios a
Study completion date
-
2020
-
12
-
31T00
:00:00
+
2021
-
04
-
20T00
:00:00
Cambios a
Date of available results
-
2021-
01
-
29T00
:00:00
+
2021-
05
-
14T00
:00:00
Cambios a
Date of first publication
-
2021-
02
-
26T00
:00:00
+
2021-
06
-
25T00
:00:00
Cambios a
Record Verification Date
-
2020
/
09
/
19
+
2022
/
10
/
14
Cambios a
Next update date
-
2021
/
09
/
19
+
2023
/
10
/
14
Cambios a
Results file
+
sites/default/files/Summary study_2.pdf
Revisión de 14 Octubre 2022 - 9:28am
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)
Primary sponsor:
Centro Nacional de Biopreparados (BioCen)
Secondary sponsor:
Not aplicable
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
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
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
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:
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
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
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