Nasalferon in respiratory infections in adults. Phase 3 clinical trial.

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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.

Acronym of Public Title:

ALMAS

Scientific title:

Efficacy and safety of Nasalferon in the treatment of acute upper respiratory tract infections in adults. Phase 3 clinical trial, compared with historical control.

Secondary indentifying numbers:

IG/IAGN/IRA/2502

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:

Yanet

Last name:

Escalona Blanchey

Medical Specialty :

First and Second Degree Specialist in Comprehensive General Medicine

Affiliation:

“Roberto M. Zulueta Cayol” Polyclinic

Postal address:

Figuras entre Diaria y Puerta Cerrada, Old Havana.

City:

Havana

Country:

Cuba

Zip Code:

10100

Telephone:

+53-78620559

Email address:

yanet.escalona@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:

Havana, “Dr. Diego Tamayo” Polyclinic, Maria Isabel Zamora Navarro, MD. First Degree Specialist in Comprehensive General Medicine.

Havana, “Ángel Arturo Aballí” Polyclinic, Lourdes Mariela Miret Navarro, MD. First 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:

20/02/2025

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

Intervention(s):

Nasalferon 5M (recombinant human interferon alpha 2b - IFN-α2b) (Experimental group): 1 drop (0.05 mL; 250,000 IU IFN-α2b) in each nostril every 8 hours (1.5 MIU IFN-α2b daily) for 5 days. If respiratory symptoms persist on the 5th day, continue treatment for 10 days.

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):

Resolution or improvement (percentage of patients) of the main respiratory symptoms (odynophagia, nasal obstruction, rhinorrhea, fever). Time of measurement: on the 3rd or 5th day after starting treatment.

Key secondary outcomes:

1) Time of evolution (days) of each of the symptoms associated with ARI and identified at the time of inclusion of the patient in the study. Time of measurement: daily, until the cessation or improvement of each symptom. 2) Percentage of patients with resolution of main respiratory symptoms. Time of measurement: 7th and 12th after starting treatment. 3) Appearance of complications specific to the disease under study, after the start of treatment (type and duration [days]). Special attention will be paid to the warning signs of acute respiratory infections (polypnea at rest >32/min, indrawing, central cyanosis, laryngeal stridor, temperature ˂35.5 °C or >39.0 °C, behavioral changes [great adynamia or psychomotor agitation], hemodynamic disorders, purulent or hemoptoic expectoration, chest pain, wheezing or chest tightness). 4) Clinical Adverse Events-AE (These will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definite), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization/prolongation of hospitalization), -Outcome (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: at 72 hours, as well as on the 5th, 7th and 12th day (in person at the clinical site, with review of the outpatient adverse event card, in the possession of each patient).

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) Compliance with diagnostic criteria (uncomplicated acute upper respiratory infection, with clinical symptoms suggestive of viral etiology, presenting at least one of the following respiratory symptoms: nasal obstruction, rhinorrhea, odynophagia, and fever. These symptoms may be accompanied by pharyngeal erythema, dry or wet cough with whitish or clear expectoration, coryza or sneezing, asthenia, myalgia, and headache). 2) Age equal or older than ≥19 years. 3) Time no longer than 48 hours since the onset of clinical symptoms. 4) Patient willingness to participate in the clinical trial.

Exclusion criteria:

1) Patients with low or complicated ARI symptoms, according to the modified Denny and Clyde classification. 2) Patient with clinical symptoms suspected of ARI of bacterial etiology. 3) Patients treated with immunomodulators or antivirals one month prior to inclusion. 4) Oncology patients with a history of chemotherapy less than two months prior to inclusion. 5) Patient with administration of any other biological product, included in another clinical trial. 6) Patient with obstructive nasal disease, referred (example: polyps). 7) History of recurrent episodes of nasal bleeding. 8) Known hypersensitivity to thiomersal and any of the components of the formulation under study.

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:

N/A: single arm study

Masking:

Open

Control group:

Historical

Study design:

Single group

Phase:

3

Target sample size:

130

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; First and Second Degree 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

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

hernandez.bernal@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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences; First and Second Degree 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

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

hernandez.bernal@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Direccion Municipal de Salud de la Habana Vieja (Centralized Ethics and Review Committee)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

05/02/2025

Postal address of Ethic Committee :

Calle Paula e/ Picota y Compostela, Habana Vieja, CP:10100, Havana, Cuba

Telephone:

+53-78620559

Email:

informaticohv@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/04/2025

Date of available results:

31/07/2025

Date of first publication:

31/10/2025

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:

RPCEC00000455

Date of Registration in Primary Registry:

13/02/2025

Record Verification Date:

2025/02/13

Next update date:

2026/02/13

Link to the spanish version:

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Nasalferon in respiratory infections in adults. Phase 3 clinical trial.

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