Revisiones para Nasal recombinant human interferon alfa-2b in ARI | Registro Público Cubano de Ensayos Clínicos

--- 6 Diciembre 2022 - 2:29pm por Gladys
+++ 13 Febrero 2023 - 12:15pm por lazara
-/12/06
+/02/13
-/12/06
+/02/13

Revisión de 13 Febrero 2023 - 12:15pm

Nasal recombinant human interferon alfa-2b 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:

NASIRA

Scientific title:

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

Acronym of Scientific Title:

IFNARI

Secondary indentifying numbers:

IG/IAGN/IR/2202

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)

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:

Carlos

Midle name:

Alberto

Last name:

Gonzalez Delgado

Medical Specialty :

2nd Degree Specialist in Pharmacology

Affiliation:

National Center for Toxicology (CENATOX)

Postal address:

31st avenue and 114th street. Marianao

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72601230

+53-72608751

Email address:

eclinicos@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:

01/02/2023

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

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 (Control): 2 drops (0.10 mL, placebo) in each nostril, 2 times a day, for 10 days. Group D (control): 1 drop (0.05 mL, placebo) in each nostril, 2 times a day, for 10 days. Stage II. Group E (Experimental): Variant selected from stage I, for 10 days. Group F (Control): Placebo with the dose administration scheme 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 (Patient recovered: PCR negative for ARI of viral etiology and absence of clinical symptoms of ARI. Patient not recovered: PCR positive for ARI of viral etiology or presence of clinical symptoms of ARI). Measurement time: 3rd day, 8th day and 10th day after starting the treatment

Key secondary outcomes:

1.- Clinical response (disappearance of clinical respiratory symptoms). Measurement time: Daily during the patient's treatment time. 2.- Virological response (negative PCR for ARI of viral etiology). Measurement time: on the 8th and 11th day after starting treatment. 3.- Severity of the disease (Classification of the disease into mild, moderate, severe and critical stages). Measurement time: Daily during the patient's treatment time. 4. Post-treatment clinical response (absence of clinical respiratory symptoms since the previous evaluation). Measurement time: on day 28 (week 4), day 56 (week 8) and day 84 (week 12) after the treatment was completed. 5. Security variables (Detection of adverse events during the physical examination of the patient or referrals). Measurement time: Daily during the patient's treatment time

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 ARI with mild symptoms (non-sustained fever ≤ 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body pain, 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 gender or skin color. 3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms. 4.- Voluntary nature 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 ARI with bacterial etiology. 3.- Individual with a clinical diagnosis of ARI with mild symptoms, without having started treatment in the 48 hours after the onset of symptoms. 4.- Individuals with ARI symptoms in moderate, severe or critical clinical classification. 5.- Individuals with decompensated chronic disease. 6.- Treatment with immunosuppressants in the last month prior to inclusion. 7.- Ongoing treatment, for any reason, with some IFN alpha formulation. 8.- Active use of any other medication or substance intranasally. 9.- Patient diagnosed with Myasthenia Gravis. 10.- Administration of any investigational drug in the 30 days prior to inclusion in the study. 11.- Individuals with hypersensitivity to thiomersal (thimerosal). 12.- Individuals with hypersensitivity to alpha interferon. 13.- Evident mental incapacity to issue 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:

608

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:

PhD in Pharmaceutical Sciences. Clinical Trial Monitor

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

31st avenue 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:

PhD in Pharmaceutical Sciences. Clinical Trial Monitor

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

31st avenue 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:

National Center for Toxicology

Status of evaluation:

In Evaluation

Status of evaluation date of Ethic Committee:

29/11/2022

Postal address of Ethic Committee :

31st avenue and 114, Havana. ZC 11400. Cuba

Telephone:

+53-72601230; +53-72608751 y +53-72743008

Correo electrónico:

eclinicos@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/07/2023

Date of available results:

30/12/2023

Date of first publication:

29/02/2024

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:

RPCEC00000412

Date of Registration in Primary Registry:

06/12/2022

Record Verification Date:

2023/02/13

Next update date:

2024/02/13

Link to the spanish version:

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Nasal recombinant human interferon alfa-2b in ARI

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