ATENEA-Co-300 study

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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:

Application of the CIGB 300 as Antiviral in the treatment of patients with a diagnosis of Covid 19. (COVID-19)

Secondary indentifying numbers:

IG/CIGB300I/CV/2001

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)

Reference number:

In process

Principal investigator

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

First name:

Leticia

Last name:

del Rosario Cruz

Medical Specialty :

1st degree specialist in Internal Medicine

Affiliation:

Military Hospital "Dr. Luis Diaz Soto"

Postal address:

Ave Monumental km 2 ½

City:

Havana

País:

Cuba

Zip Code:

19130

Telephone:

+53-7680000

Email address:

lrosarioc@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:

Not applicable

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/06/2020

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:

Confirmed patients to COVID-19

Intervention(s):

Group I (experimental): Treatment with CIGB 300 at the dose of 2.5 mg / kg, intravenously, daily for 5 days + treatment established in the national action protocol for COVID-19. Group II (control): Treatment established in the national action protocol for COVID-19.

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):

Reduction of the time to the negativization of the coronavirus detection test (time to the negative of the coronavirus detection test by PCR-RT in the nasopharynx). Measurement time: 48 hours and on the 7th day after starting the treatment.

Key secondary outcomes:

1) Clinical response to treatment according to the patient's condition at the time of inclusion (defined according to the NIH Guidelines): the improvement of the clinical status of the treated patients and non-progression to a serious or critical condition of the disease will be evaluated, and death. Measurement time: Daily during the patient's hospital stay (7 days). 2) Biological markers predictive of response to CIGB 300 (plasma HMGB-1 levels and 45S and CD 47 levels by real-time PCR of RNA obtained from peripheral blood mononuclear cells). Measurement time: before treatment and 6 hours after the 5th administration. 3) Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (event name), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of some 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 study period (7 days).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1) Patients who meet the diagnostic criteria for COVID 19 in categories 1 through 4 of the NIH guidelines. 2) Age over 18 years. 3) Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1) Pregnancy or lactation at the time of inclusion in the study. 2) Patients included in another clinical trial. 3) Diseases that compromise the patient's state of consciousness or their possibility of giving their informed consent or collaborating in the trial. 4) Critical illness, category 5 of the NIH Guidelines.

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:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

20

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:

Idania

Last Name:

Baladron Castrillo

Specialty:

2nd degree specialist in Gynecology and Obstetrics.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, +53-72087465

Email :

idania.baladron@cigb.edu.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:

Silvio

Last Name:

Perea Rodriguez

Specialty:

Doctor in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+537-2716022

Email :

silvio.perea@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Military Hospital "Dr. Luis Diaz Soto"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/05/2020

Postal address of Ethic Committee :

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

Telephone:

+53-77680715

Correo electrónico:

lrosarioc@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/06/2020

Date of available results:

17/07/2020

Date of first publication:

31/07/2020

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:

RPCEC00000317

Date of Registration in Primary Registry:

28/05/2020

Record Verification Date:

2020/05/28

Next update date:

2021/05/28

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

ATENEA-Co-300 study

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