AVATAR-2020

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:

AVATAR-2020

Scientific title:

Nasal and Sublingual Application of the CIGB 2020 Therapeutic Vaccine in patients with SARS-CoV-2 infection. Randomized controlled clinical trial (COVID-19)

Acronym of Scientific Title:

AVATAR-2020

Secondary indentifying numbers:

IG/ VTNSL /CV/2003

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.

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:

Madeleyny

Last name:

Tamayo Rodriguez

Medical Specialty :

1st degree specialist in Internal Medicine , Assistant Professor .

Affiliation:

Military Hospital "Dr. Luis Diaz Soto"

Postal address:

Ave Monumental km 2 ½

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-77683450

Email address:

madeleynytr@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:

Pending

Date of first enrollment:

01/04/2021

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:

COVID-19

Health condition(s) code:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group I (experimental): Treatment with CIGB 2020 nasal spray: on days 1 and 7 and sublingual CIGB2020: daily during 7 days. The dose for both routes of administration (100 µg HBsAg + 100 µg HBcAg / 1 mL /) + Treatment established in the national action protocol for COVID-19. Group II (control): Treatment established in the national action protocol for COVID-19.

Intervention code:

Immunotherapy, Active

Administration, Sublingual

Administration, Intranasal

Nasal Sprays

Intervention keyword:

CIGB 2020

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):

Clinical Response (It will assess to a) No progression to Symptomatic State or higher of the disease in Asymptomatic patients and, b) No progression to a higher state of the disease (Moderate, Severe Pneumonia) and Resolution of symptoms in mild symptomatic patients). Measurement time: Day 7.

Key secondary outcomes:

1) Immunogenicity (It will assess to a) specific anti-RBD IgG antibodies (geometric mean ) b) Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that ≥ 2 times the initial determination of the antibody titer) Time measurement: on days 9 (48 hours after treatment), at 3 and 6 months. 2) Time to achieve virological response according to PCR Ex Nasopharyngeal (Time elapsed from the first positive PCR to the first negative PCR, (It will assess to a) geometric mean in both treatment groups.b) Proportion of patients with negative PCR). Measurement time: day 8 (48 hours after treatment) 3) Clinical Adverse Events (AE). They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Causality relationship (not related, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: daily throughout the study execution 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:

35 years

Maximum age:

None

Inclusion criteria:

1) Asymptomatic or mild symptomatic Sars Cov 2 PCR-positive patients (Clinical Categories 1 and 2 of the NIH classification). 2) Age over 35 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 ability to give informed consent or collaborate in the trial. 4) Moderate, severe or critical stage (3, 4 and 5) of the NIH classification. 5) Anatomical, functional or psychological conditions that prevent the nasal or sublingual application of the Produ

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:

2-3

Target sample size:

354

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:

Pablo

Middle Name:

Arsenio

Last Name:

Diaz Reyes

Specialty:

First Degree Specialist in Neonatology

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

Email :

pablo.dias@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:

Julio

Middle Name:

Cesar

Last Name:

Aguilar Rubido

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

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

julio.aguilar@cigb.edu.cu [3]

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:

04/01/2021

Postal address of Ethic Committee :

Ave Monumental Km 2 ½, Habana del Este, Havana, ZC:19130, Cuba

Telephone:

+53-77680715

Email:

idelsisem@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/04/2022

Date of available results:

31/07/2022

Date of first publication:

31/10/2022

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:

RPCEC00000353

Date of Registration in Primary Registry:

01/03/2021

Record Verification Date:

2021/03/02

Next update date:

2022/03/02

Link to the spanish version:

Click here [4]