NCT06183229

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Influenza
• Acute Respiratory Infection

Interventions

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

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-03-01
• Completion: 2024-06-10
• First posted: 2023-12-27
• Last updated: 2025-04-29

Locations

2 sites across 1 country: Russia