OLIVO Study

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:

Intranasal administration of recombinant human interferon alfa-2b as prophylaxis of SARS-CoV-2 infection. (COVID-19)

Secondary indentifying numbers:

IG/IAGN/VS/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.

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 :

05/10/2020

Reference number:

412/05-011-2013

Principal investigator

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

First name:

Lidice

Last name:

Josue Diaz

Medical Specialty :

2nd Degree Specialist in Psychiatry

Affiliation:

Central Military Hospital “Dr. Carlos J. Finlay"

Postal address:

Avenida 31 y 114, Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-72743015

Email address:

docenciahfinlay@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:

Complete

Date of first enrollment:

12/10/2020

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:

Prophylaxis of SARS-CoV-2 infection

Health condition(s) code:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Nidovirales Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

- Recombinant human interferon alpha 2b (10M; Nasalferon): 1 drop (0.05 mL; 500,000 IU IFN-α2b) in each nostril, twice daily (2.0 MIU daily IFN-α2b), for 10 days.

Intervention code:

Interferon alpha-2

Interferon-alpha

Interferons

Administration, Intranasal

Nasal Sprays

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):

Safety - Adverse clinical 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 (no related, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, 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 in the first 10 days (coinciding with the period of administration of the research product), and at 16 and 23 days after the start of treatment. - Pharmacodynamic activity associated with IFN alpha (The local and systemic expression of the protein 2-5 oligoadenylate synthetase 1 will be evaluated in samples of oropharyngeal scraping and peripheral blood). Measurement time: at the beginning, 24 and 72 hours, 5th day and days 16 and 23.

Key secondary outcomes:

- Antiviral protection of the individual (active surveillance of respiratory symptoms and other clinical manifestations will be carried out. The type, number, intensity and duration of symptoms will be analyzed). Measurement time: throughout the study execution period (Up to day 23).

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) Individuals aged ≥ 19 years. 2) Voluntariness of the subject by signing the informed consent.

Exclusion criteria:

1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2. 2) Treatment with immunosuppressants in the last month prior to inclusion. 3) Ongoing treatment, for any reason, with any IFN formulation. 4) Acute illnesses in the last 30 days. 5) Use of any other medication intranasally. 6) Subjects who underwent tonsillectomy. 7) History of allergic rhinitis and recurrent episodes of nasal bleeding. 8) Active chronic asthma. 9) Patients with myasthenia gravis. 10) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 11) Administration of an investigational drug in the 30 days prior to inclusion in the study. 12) Known hypersensitivity to thiomersal and any of the components of the formulation under study. 13) Pregnancy or breastfeeding. 14) Obvious mental incapacity to issue consent and act accordingly with the study.

Type of population:

Adults

Type of participant:

Healthy volunteers

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:

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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences; 1st and 2nd grade specialist in Hygiene and Epidemiology.

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:

+53-72716022

Email :

hernandez.bernal@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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences; 1st and 2nd grade specialist in Hygiene and Epidemiology.

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:

+53-72716022

Email :

hernandez.bernal@cigb.edu.cu [2]

Research Ethics Committees

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

Name of Research Ethics Committees:

Central Military Hospital “Dr. Carlos J. Finlay"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/09/2020

Postal address of Ethic Committee :

Avenida 31 y 114, Marianao, Havana, ZC: 11500, Cuba

Telephone:

+53-72743015

Correo electrónico:

docenciahfinlay@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

06/11/2020

Date of available results:

21/11/2020

Date of first publication:

30/12/2020

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:

RPCEC00000337

Date of Registration in Primary Registry:

01/10/2020

Record Verification Date:

2023/02/28

Next update date:

2024/02/28

Link to the spanish version:

Click here [3]