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

NCT06183229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-04-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Tatiana V Kharitonova, MD PhD · STPF POLYSAN

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-03-01
Completion
2024-06-10

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06183229 on ClinicalTrials.gov