Nasalferon in ARI

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:

INDIRA

Scientific title:

Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose and frequency study. INDIRA study. Phase II-III trial

Acronym of Scientific Title:

NASALFERON-ARI

Secondary indentifying numbers:

IG/IAGN/IR/2201

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), Cuban Ministry of Public Health (MINSAP)

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:

Sonia

Last name:

Resik Aguirre

Medical Specialty :

Second degree specialist in Microbiology

Affiliation:

Institute of Tropical Medicine Pedro Kouri

Postal address:

Avenida Novia del Mediodia, KM 6 1/2, La Lisa

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72553160

+53-72553162

Email address:

docencia@ipk.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, Vedado Polyclinic, Jorge Alvarez Pita, MD. Second degree specialist in Comprehensive General Medicine.

Havana, Plaza de la Revolucion Polyclinic, Alejandro Flores Cabrera, MD. Second degree specialist in Comprehensive General Medicine.

Havana, Martires del Corynthia Polyclinic, Yanet Prado Martinez, MD. Second degree specialist in Comprehensive General Medicine.

Havana, April 19 Polyclinic, Bertha Santos Vega, MD. Second degree specialist in Comprehensive General Medicine.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/09/2022

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

Infections

Intervention(s):

Stage I Group A (Experimental): 2 drops (0.10 mL, 500,000 IU Nasalferon) in each nostril, 2 times a day, for 10 days. Total daily dose: 2 million IU. Group B (Experimental): 1 drop (0.05 mL, 250,000 IU Nasalferon) in each nostril, 2 times a day, for 10 days. Total daily dose: 1 million IU. Group C (Experimental): 1 drop (0.05 mL, 250,000 IU Nasalferon) in each nostril, once a day, for 10 days. Total daily dose: 500,000 IU. Stage II. Group D (Experimental): Selected variant of Stage I, for 10 days. Group E (Control): Placebo with the dose and frequency administration schedule of the selected variant, for 10 days.

Intervention code:

Interferon alpha-2

Interferon alpha

Interferons

Placebos

Administration, Intranasal

Intervention keyword:

Nasalferon, drops

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):

Patient Recovery (Recovered patient: PCR negative for AKI of viral aetiology and absence of clinical symptoms of AKI. Non-recovered patient: PCR positive for AKI of viral aetiology or presence of clinical symptoms of AKI). Measurement time: 8th day after starting treatment.

Key secondary outcomes:

1.- Clinical response (disappearance of clinical respiratory symptoms). Measurement time: Daily during the treatment time of the patient. 2.- Virological response (PCR negative for ARI of viral aetiology). Measurement time: on the 8th and 11th day of starting treatment. 3.- Proportion of recovered patients (Quotient number of patients recovered/number of patients included). Measurement time: 8th and 11th day of starting 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:

19 years

Maximum age:

80 years

Inclusion criteria:

1.- Clinical diagnosis of AKI with mild symptoms (non-sustained fever ≤ 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body aches, malaise, diarrhea and/or vomiting. White nasal discharge (clear ) or transparent Radiology (Rx) normal Oxygen saturation greater than 95%). 2.- Age between 19 and 80 years, regardless of sex or skin color. 3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms. 4.- Willingness of the patient to participate in the trial.

Exclusion criteria:

1.- Individuals under 19 years of age and over 80. 2.- Individuals with suspected clinical diagnosis of AKI with bacterial etiology. 3.- Individual with a clinical diagnosis of AKI with mild symptoms, without having started treatment within 48 hours after the onset of symptoms. 4.- Individuals with symptoms of AKI in moderate, severe or critical clinical classification. 5.- Individuals with chronic decompensated disease. 6.- Treatment with immunosuppressants in the last month prior to inclusion. 7.- Ongoing treatment, for any reason, with any formulation of IFN alpha. 8.- Active use of some other drug or substance intranasally. 9.- Patient diagnosed with Myasthenia Gravis. 10.- Administration of an investigational drug in the 30 days prior to inclusion in the study. 11.- Individuals with hypersensitivity to thiomersal (thimerosal). 12.- Individuals with hypersensitivity to interferon alfa. 13.- Evident mental inability to give consent and act accordingly with the study. 14.- Pregnancy, puerperium or lactation.

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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

495

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:

Hugo

Last Name:

Nodarse Cuni

Specialty:

Doctor of Pharmaceutical Sciences. Clinical Trial Advisor

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

Ave 31 e/t 158 and 190. Cubanacan. Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-52167605

Email :

hugo.nodarse@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:

Hugo

Last Name:

Nodarse Cuni

Specialty:

Doctor of Pharmaceutical Sciences. Clinical Trial Advisor

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

Ave 31 e/t 158 and 190. Cubanacan. Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-52167605

Email :

hugo.nodarse@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Pedro Kouri Medicine Tropical Institute (centralized)

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

06/07/2022

Postal address of Ethic Committee :

Avenida Novia del Mediodia, Km 6 1/2, La Lisa, ZC 11400, Havana, Cuba

Telephone:

+5372020425, +5372553160

Correo electrónico:

docencia@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

11/12/2022

Date of available results:

17/12/2022

Date of first publication:

28/02/2023

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:

RPCEC00000407

Date of Registration in Primary Registry:

29/07/2022

Record Verification Date:

2022/07/29

Next update date:

2023/07/29

Link to the spanish version:

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Nasalferon in ARI

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