Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza (NCT06183229) | Clinical Trial Compass
CompletedPhase 3
Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza
Russia166 participantsStarted 2023-09-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).
What they're measuring
1
Proportion of influenza/other acute respiratory viral infection in the study groups
Timeframe: 14 days
Trial details
NCT IDNCT06183229
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company