Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

NCT03707912 | Completed Phase 4 Results

• 1 other identifier: MMH-AN-005
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 19

Brief Summary

Purpose of the study: • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.

Conditions

Acute Respiratory Viral Infections

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.

  Based on a patient diary. ARVI is clinically diagnosed and/or Real-time reverse transcription polymerase chain reaction (PCR) confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome).

  On days 1-7 of the observation period.

Secondary Outcomes (6)

• ARVI Severity.

  On days 1-6 of the observation period.

• Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).

  On day 2, 3, 4, 5, and 6.

• Time to Resolution of ARVI (PCR-confirmed) Symptoms.

  On days 2-6 of the observation period.

• Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).

  On day 2, 3, 4, 5, and 6.

• Dosing Frequency of Antipyretics if Indicated.

  On day 1, 2, and 3.

Study Arms (2)

Anaferon

EXPERIMENTAL

1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day. Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.

Drug: Anaferon

Placebo

PLACEBO COMPARATOR

Placebo using Anaferon regimen until the end of the study.

Drug: Placebo

Interventions

Anaferon DRUG

Oral administration.

Anaferon

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender aged 18-70 years.
• Diagnosis of acute respiratory viral infection (ARVI) based on medical examination: axillary temperature ≥ 37,8 ° C at examination + non-specific/flu-like symptom score ≥4, nasal/throat/chest symptom score ≥2.
• The first 24 hours after ARVI onset.
• Seasonal rise in ARVI incidence.
• Patients giving their consent to use reliable contraception during the study.
• Signed patient information sheet (informed consent form).

You may not qualify if:

• Suspected pneumonia, bacterial infection (including otitis media, sinuitis, urinary tract infection, meningitis, sepsis, etc.), requiring the administration of antibacterial drugs from the first day of the disease.
• Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
• Clinical symptoms of severe influenza/ARVI requiring hospitalization.
• Subjects requiring concurrent antiviral products forbidden by the study.
• Medical history of primary and secondary immunodeficiency.
• Oncologic conditions /suspected oncologic conditions.
• Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
• Impaired glucose tolerance, diabetes mellitus.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• Allergy/ hypersensitivity to any component of the study drug.
• Consumption of narcotics, alcohol \> 2 alcohol units per day, mental diseases.
• Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
• Participation in other clinical trials for 3 months prior to enrollment in this study.
• Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
• Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (19)

Regional State Budgetary Healthcare Institution "City Hospital No. 5, Barnaul"

Barnaul, 656045, Russia

Location

Non-governmental health care institution "Road Clinical Hospital at Chelyabinsk station JSC" Russian Railways "

Chelyabinsk, 454000, Russia

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Krasnogorsk city hospital №1

Krasnogorsk, 143408, Russia

Location

The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences

Moscow, 117593, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation

Moscow, 119121, Russia

Location

Podolskaya City Clinical Hospital No. 3

Podolsk, 142105, Russia

Location

Central City Clinical Hospital of Reutov

Reutov, 143964, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"

Saint Petersburg, 193312, Russia

Location

St. Petersburg State Health Care Institution "City Polyclinic №117"

Saint Petersburg, 194358, Russia

Location

Road Clinical Hospital JSC Russian Railways

Saint Petersburg, 195271, Russia

Location

LLC "Research Center Eco-Security"

Saint Petersburg, 196143, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 51"

Saint Petersburg, 196211, Russia

Location

St. Petersburg City State Hospital "City Hospital No. 26"

Saint Petersburg, 196247, Russia

Location

St. Petersburg State Budgetary Institution of Health "City Polyclinic №34"

Saint Petersburg, 197198, Russia

Location

Saratov City Clinical Hospital № 2 named after VI Razumovsky

Saratov, 410028, Russia

Location

Regional State Budgetary Healthcare Institution "Clinical Hospital No.1"

Smolensk, 214006, Russia

Location

Yaroslavl State Medical University

Yaroslavl, 150000, Russia

Location

MeSH Terms

Interventions

anaferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: October 9, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: September 2, 2020
• Results First Posted: September 2, 2020

Record last verified: 2020-08

Locations

RU (19)