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 range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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