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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza; Acute Respiratory Infection
• Intervention / Treatment: Drug: Cycloferon; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 578
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aleksey L Kovalenko, Doc Biol Sci; Phone Number: +7 (812) 448-22-22; Email: science@polysan.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 196143
    • Recruiting
    • Research Center for Eco-safety, Ltd.
    • Contact: Vasily B Vasilyuk, MD, PhD; Phone Number: +79013044248; Email: vasilyuk_vb@ecosafety.ru
  • Saint-Petersburg, Russian Federation
    • Recruiting
    • City Outpatient Clinic #117
    • Contact: Diana N Alpenidze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female subjects aged 18 to 65 years inclusive.
2. Written informed consent.
3. Co-living with persons who has developed influenza or other acute respiratory viral infection, diagnosed no more than 3 days ago.
4. No signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion in the study.
5. 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:

1. Known or suspected hypersensitivity to meglumine acridone acetate and/or any other component of the drug/placebo.
2. Lactose intolerance
3. Diseases of the digestive system in the acute stage (erosions, gastric and/or duodenal ulcers, gastritis and duodenitis).
4. History of allergic reactions.
5. Decompensated liver cirrhosis.
6. Diseases of the thyroid gland.
7. Congenital or acquired immunodeficiency.
8. Signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion.
9. Positive result of a rapid test for the presence of SARS-CoV-2 at the time of screening.
10. Vaccination to prevent COVID-19 and/or influenza within 6 months before screening, planned vaccination during a clinical trial.
11. History of positive test result for HIV types 1 or 2.
12. Pregnancy or breastfeeding period (for women).
13. Alcoholism, drug addiction, substance and/or drug abuse in history and/or at the time of screening.
14. Participation in another clinical trial within 3 months before inclusion.
15. Subject is already receiving cycloferon.
16. Subject is receiving prohibited therapy or was receiving it within 30 days prior to screening.
17. Failure to observe the subject during the study period.
18. 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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cycloferon; Intake of Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8.	Drug: Cycloferon; 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 Comparator: Placebo; Intake of Placebo, 4 tablets 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of influenza/other acute respiratory viral infection in the study groups	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.	14 days

Collaborators and Investigators

• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
• Investigators: Study Director: Tatiana V Kharitonova, MD PhD, STPF POLYSAN

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: influenza; prevention; acute respiratory viral infection; grippe
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Physiological Effects of Drugs; Immunologic Factors; Interferon Inducers; 10-carboxymethyl-9-acridanone
• Other Study ID Numbers: CCF-III-TAB-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No