CIGB 2020 in contacts and SARS-CoV-2 infection suspects

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:

Randomized control clinical trial of CIGB 2020 in contacts and SARS-CoV-2 infection suspects (COVID-19)

Secondary indentifying numbers:

CIGB 2020-01

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), Havana. Ministry of Public Health, Cuba.

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)

Authorization date :

26/03/2020

Reference number:

In process

Principal investigator

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

First name:

Clara

Midle name:

Julia

Last name:

Cuesta Dieguez

Medical Specialty :

1st degree specialist in Internal Medicine.

Affiliation:

Military Hospital "Dr. Luis Diaz Soto"

Postal address:

Ave Monumental 2 ½

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-7680000

Email address:

idelsisem@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:

Not applicable

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

27/03/2020

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:

Contacts and SARS-CoV-2 infection suspects

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

suspected of SARS-CoV-2 infection

Intervention(s):

- Control Group: Conventional treatment Basic (conventional) treatment planned in the hospital for the management of contacts and suspects of SARS-CoV-2 infection. - Experimental Group: Conventional treatment + CIGB 2020 vaccine Basic (conventional) treatment planned in the hospital for the management of contacts and suspects of SARS-CoV-2 infection. In addition, patients will receive treatment with the CIGB 2020 vaccine nasal (scheme 0-7-14 days) and sublingually (one daily dose for 14 days).

Intervention code:

Immunotherapy, Active

Administration, Sublingual

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):

Activation of markers of the innate immune system (in oropharyngeal scraping: relative concentration of dendritic cells; phenotypic analysis of leukocyte cells; transcriptional analysis of elements of molecules related to the immune response with expression at the level of epithelium and infiltrating leukocytes; quantification by ELISA of cytokines related to systemic inflammation such as IL-6, TNF alpha, IFN alpha and gamma, among other mediators of systemic inflammation, etc.). Measurement time: at baseline and, on days 4 and 8 post-treatment.

Key secondary outcomes:

Percentage of patients with appearance of the SARS-CoV-2 virus (by PCR-RT). Measurement time: Sometime during the 14-day follow-up. Percentage of patients with changes in the immune response: 1) Serum cytokine pattern (variable to verify aggravation); 2) Proportion of dendritic cells of the total (Cytology, FACs); 3) Ratio of activation of dendritic cells, NK and monocytes / macrophages by cytometry (activation markers, HLA DR and costimulatory factors by RT PCR); 4) Gene expression of TLR agonists in whole blood by RT-PCR; 5) Characterization of cellular subpopulations and senescence markers. Measurement time: bat baseline and, on days 4 and 8 post-treatment. Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (name of the event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, Definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event). Measurement time: daily throughout the follow-up of the subjects. Laboratory (numerical values of Blood chemistry test: hemogram, hematocrit, leukogram with differential, platelet count, prothrombin time, C-reactive protein, ALAT, ASAT, glycemia, creatinine, cholesterol, triglycerides, albumin and bilirubin). Measurement time: at baseline and, on days 4 and 8 post-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 equal to or greater than 60 years, of both sexes. 2- Cases defined as contact or suspected of SARS-CoV-2 infection. 3- Voluntary nature of the subject to participate expressed through the delivery of signed informed consent.

Exclusion criteria:

1-Established lung disease, pneumonia defined by imaging. 2- Serious evolution of SARS-CoV-2 infection (extrapulmonary systemic hyperinflammation syndrome). 3- AST or ALT> 2 times normal value. 4- Abnormal bilirubin (total bilirubin> 1.2 mg / dL, direct bilirubin> 0.4 mg / dL). 5- Creatinine> 2.0 mg / dl. 6- Use of immunosuppressive drugs within 1 month of recruitment, or chemotherapy. 7- Hemoglobin <10 g / dl. 8- Platelets <100,000 / ml. 9- History of allergy to any of the ingredients of the vaccine under study. 10- Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or to monitor the patient.

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:

Other

Other purpose:

Prevention or treatment in early stage

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Doctor in medicine. 1st degree specialist in Clinical Biochemistry.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

zurina.cinza@cigb.edu.cu [2]

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:

Zurina

Last Name:

Cinza Estevez

Specialty:

Doctor in medicine. 1st degree specialist in Clinical Biochemistry.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

zurina.cinza@cigb.edu.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

Military Hospital "Dr. Luis Díaz Soto"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

26/03/2020

Postal address of Ethic Committee :

Ave Monumental 2 ½, Habana del Este, La Habana, C.P:19130, Cuba

Telephone:

53-7680000

Email:

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

15/07/2020

Date of available results:

30/07/2020

Date of first publication:

15/08/2020

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:

RPCEC00000306

Date of Registration in Primary Registry:

13/04/2020

Record Verification Date:

2020/07/07

Next update date:

2021/07/07

Link to the spanish version:

Click here [3]