InfluenzaPhase 3NCT06183229
Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza
A Phase 3 study testing Cycloferon in people with Influenza and Acute Respiratory Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Acute Respiratory Infection
- What is being tested?
- Cycloferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 2 sitesRussia
- Study dates
- 15 Sep 2023to 10 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- History of allergic reactions.
- Decompensated liver cirrhosis.
- Diseases of the thyroid gland.
Show all 18Show fewer
- Congenital or acquired immunodeficiency.
- Signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion.
- Positive result of a rapid test for the presence of SARS-CoV-2 at the time of screening.
- Vaccination to prevent COVID-19 and/or influenza within 6 months before screening, planned vaccination during a clinical trial.
- History of positive test result for HIV types 1 or 2.
- Pregnancy or breastfeeding period (for women).
- Alcoholism, drug addiction, substance and/or drug abuse in history and/or at the time of screening.
- Participation in another clinical trial within 3 months before inclusion.
- Subject is already receiving cycloferon.
- Subject is receiving prohibited therapy or was receiving it within 30 days prior to screening.
- Failure to observe the subject during the study period.
- 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.).
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Research Center for Eco-safety, Ltd.
Saint Petersburg, 196143
City Outpatient Clinic #117
Saint Petersburg
About this study
Official title: 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.
- Conditions
- Influenza, Acute Respiratory Infection
- Being tested
- Cycloferon, Placebo
- Keywords
- influenza, acute respiratory viral infection, grippe, prevention
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloferonDrug
Also called Meglumine acridоnacetate
Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8.
PlaceboDrug
Placebo tablets, 4 tablets per day on days 1, 2, 4, 6 and 8
| Study group | Role | What they receive |
|---|---|---|
| Cycloferon | Experimental | Intake of Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8. Receives: Drug: Cycloferon |
| Placebo | Placebo comparator | Intake of Placebo, 4 tablets per day, on days 1, 2, 4, 6 and 8. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start15 Sep 2023
- Primary completion1 Mar 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized, two-parallel group comparative study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana V Kharitonova, MD PhD, Study director, STPF POLYSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183229
- Sponsor's protocol ID
- CCF-III-TAB-2023
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06183229
- Acronym / sponsor ID
- CCF-III-TAB-2023
- Conditions
- Influenza, Acute Respiratory Infection
- Keywords
- influenza, acute respiratory viral infection, grippe, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized, two-parallel group comparative study
| Arm | Type | Receives |
|---|---|---|
| Cycloferon | Experimental | Drug: CycloferonIntake of Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8. |
| Placebo | Placebo comparator | Drug: PlaceboIntake of Placebo, 4 tablets per day, on days 1, 2, 4, 6 and 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
- History of allergic reactions.
- Decompensated liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycloferonAlso: Meglumine acridоnacetateCycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8. | Drug | Cycloferon |
| PlaceboPlacebo tablets, 4 tablets per day on days 1, 2, 4, 6 and 8 | Drug | Placebo |
Primary outcome
Proportion of influenza/other acute respiratory viral infection in the study groups
Time frame: 14 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana V Kharitonova, MD PhD study director
STPF POLYSAN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cycloferon in people with Influenza and Acute Respiratory Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of influenza/other acute respiratory viral infection in the study groups (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.