CIGB2020- ARI elderly contacts

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.

Acronym of Public Title:

PROFIRA

Scientific title:

Assessment of the effect and safety of CIGB2020 in asymptomatic subjects ≥ 60 years old, contacts of patients diagnosed of acute respiratory infections (ARI), as compared to a control group from the same population (COVID-19)

Acronym of Scientific Title:

PROFIRA

Secondary indentifying numbers:

CIGB-2020-4

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB)

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Aliucha

Last name:

Diaz Curbelo

Medical Specialty :

First Degree Specialist in Comprehensive General Medicine, Assistant Professor, Master of Science in Comprehensive Child Care, Diploma in Health Management in Infectious Diseases

Affiliation:

Municipal Health Direction of Cotorro

Postal address:

Ave 1st, No. 68, El Paraiso, Cotorro

City:

Havana

País:

Cuba

Zip Code:

14000

Telephone:

+53-56073778

Email address:

aliuchadc@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:

Havana, Rafael Valdes Menendez Policlinic, Mileisy Romero Zayas, MD. Integral General Medicine Specialist

Havana, Efrain Mayor Amaro Policlinic, Kenia Hidalgo Leon, MD. Integral General Medicine Specialist

Havana, Cuatro Caminos Policlinic, Aime de la Caridad Alfonso Alfonso, Bachelor Degree in Defectology

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

12/03/2021

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:

Acute Respiratory Infection (ARI)

Health condition(s) code:

Respiratory Tract Infections

Respiratory Tract Diseases

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Disease Prevention

Immunosenescence

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group I (Experimental): CIGB 2020 spray, by nasal route, an action of 0.1 mL in each nostril, repeat up to 5 times at intervals of 5 minutes (days 1 and 7). CIGB 2020 drops, by sublingual route, 5 drops, repeat up to 5 times at intervals of 5 minutes (daily, for 7 days). The daily dose administered nasally and sublingually is the same: 0.10 mg HBsAg + 0.10 mg HBcAg/1.0 mL/dose. Group II (Control): No intervention.

Intervention code:

Immunotherapy, Active

Administration, Sublingual

Nasal Sprays

Administration, Intranasal

Intervention keyword:

CIGB 2020 vaccine

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):

Appearance of SARS CoV2 virus infection, flu or other febrile syndromes (Yes, No). Measurement time: 2 months.

Key secondary outcomes:

For assessment 1. Time to the appearance of clinical symptoms. Measurement time: 2 months. 2. Nature and duration of the symptoms and their intensity. Measurement time: 2 months or during the symptomatic period. 3. Appearance of other infectious diseases. Measurement time: 2 months. 4. Hospitalization time. Measurement time: 2 months, or until the end of the hospitalization. For safety 5. Adverse Events-AE (Occurrence of an AE in the subject (Yes, No), Description of the AE (Name of the AE), Duration of the EA (Difference in dates between the start and end of the event), AE intensity (Mild, Moderate, Severe), Severity of the AE (Serious, Not serious), Attitude regarding the study treatment (No changes, Dose modification, Temporary interruption, Definitive interruption of the study treatment), AE result (Recovered, Improved, Persists, Sequelae), Causation relationship (Very Probable, Probable, Possible, Improbable, Not related, Not evaluable)). Measurement time: 1st hour, 24 hours and up to 28 days after the application of the product.

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. Adults ≥ 60 years old, both sexes. 2. All subjects ≥ 60 years old, contacts of patients diagnosed with flu, cold, dengue fever, SARS-CoV2 or other acute respiratory infections to be randomized during the study. 3. Subjects having agreed their informed consent to participate in the study.

Exclusion criteria:

1. Diagnostic of SARS-CoV-2 infection since the day 14th previous to recruitment. 2. Use of immunosuppressor drugs during one month previous to recruitment. 3. Liver cirrhosis by HBV or liver transplant due to HBV. 4. Any problem avoiding the addequate follow-up of the contact older than sixty. 5. Terminal disease at the moment of recruitment. 6. History of allergy to some of the ingredients of the vaccine under study 7. Pregnancy or lactancy

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:

Randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

1440

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:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

2nd degree specialist in Surgery, Doctor of Medical Science, Master in Clinical Trials, Senior professor

Affiliation:

National Coordinating Center of Clinical Trials (CENCEC)

Postal Address:

5ta A, e/ 60 y 62, Miramar, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164221

Email :

aceliac@cencec.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:

Eduardo

Last Name:

Penton Arias

Specialty:

2nd Degree Specialist in Clinical Biochemistry, Doctor of Science, Full Professor, Senior Researcher, Senior Academician, Cuban Academy of Sciences (ACC)

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

31 Ave e/ 158 and 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72718008 ext. 3216

Email :

eduardo.penton@cigb.edu.cu

eduardopenton45@gmail.com

Research Ethics Committees

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

Name of Research Ethics Committees:

Faculty of Medical Sciences "Miguel Enriquez" (centralized)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

23/02/2021

Postal address of Ethic Committee :

Ramon Pinto No. 202 entre Ensenada y Villanueva, Luyano ZC. 10700. Havana, Cuba

Telephone:

+53-76996062

Correo electrónico:

labinfme@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

12/08/2021

Date of available results:

31/08/2021

Date of first publication:

15/09/2021

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:

RPCEC00000356

Date of Registration in Primary Registry:

11/03/2021

Record Verification Date:

2021/03/15

Next update date:

2022/03/15

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

CIGB2020- ARI elderly contacts

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