Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza

Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.

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Key information

Conditions

Influenza Acute Respiratory Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

City Outpatient Clinic #117, Saint Petersburg, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female subjects aged 18 to 65 years inclusive.
Written informed consent.
Co-living with persons who has developed influenza or other acute respiratory viral infection, diagnosed no more than 3 days ago.
No signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion in the study.
For women with preserved reproductive potential - a negative pregnancy test and consent to use approved methods of contraception during the entire period of participation in the study; for men - consent to use approved methods of contraception during the entire period of participation in the study and for 3 weeks after the end of the study.

Exclusion criteria

Known or suspected hypersensitivity to meglumine acridone acetate and/or any other component of the drug/placebo.
Lactose intolerance
Diseases of the digestive system in the acute stage (erosions, gastric and/or duodenal ulcers, gastritis and duodenitis).
History of allergic reactions.
Decompensated liver cirrhosis.
Diseases of the thyroid gland.
Congenital or acquired immunodeficiency.
Signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion.
Positive result of a rapid test for the presence of SARS-CoV-2 at the time of screening.
Vaccination to prevent COVID-19 and/or influenza within 6 months before screening, planned vaccination during a clinical trial.
History of positive test result for HIV types 1 or 2.
Pregnancy or breastfeeding period (for women).
Alcoholism, drug addiction, substance and/or drug abuse in history and/or at the time of screening.
Participation in another clinical trial within 3 months before inclusion.
Subject is already receiving cycloferon.
Subject is receiving prohibited therapy or was receiving it within 30 days prior to screening.
Failure to observe the subject during the study period.
Other reasons that, in the opinion of the researcher, prevent the subject from participating in the study or create an unreasonable risk (for example, a history of autoimmune diseases, etc.).

Treatment and study plan

Cycloferon

Drug

Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8.

Other names: Meglumine acridоnacetate

Placebo

Drug

Placebo tablets, 4 tablets per day on days 1, 2, 4, 6 and 8

Primary outcomes

Proportion of influenza/other acute respiratory viral infection in the study groups

Time frame: 14 days

the proportion of subjects with clinically manifest and laboratory confirmed influenza or other acute respiratory viral infection, developed within days 1-14 of the study.

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study title

Double-blind Placebo-controlled Randomized Trial of Efficacy and Safety of Cycloferon, Enteric-coated Tablets, 150 mg, for Post-exposure Prophylaxis of Acute Respiratory Viral Infection and Influenza

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 27, 2023
Registry last updated: Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed