Acute Respiratory Viral InfectionNCT06286254
Study of Safety and Efficacy of the Drug Cycloferone in Patients with Acute Respiratory Viral Infection
An observational study of Acute Respiratory Viral Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 13 sites in Russia.
Trial summary
The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Respiratory Viral Infection
- What is being tested?
- Cycloferone
- Type of treatment
- Pill or oral medicine
- How many people
- 742 participants
- Where
- 13 sitesRussia
- Study dates
- 20 Sep 2023to 30 Sep 2024
- Phase
- Observational
- 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
Study population: Patients with symptoms of ARVI receiving the therapy at the outpatient stage.
Who may be able to join
- Male and female patients aged from 18 to 65 years.
- According to the routine clinical practice, a patient is scheduled to receive the treatment as per one of the following regimens:
- Basic therapy of ARVI1 + Cycloferone®.
- Basic therapy of ARVI1 + Arbidol®.
- Presence of symptoms of ARVI:
- Presence of two and more symptoms of moderate severity or three and more mild symptoms in accordance with the WURSS-21 questionnaire;
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- Presence of two and more symptoms of moderate severity or three and more mild symptoms in accordance with the CCQ questionnaire;
- Presence of hyperthermia episodes ≥ 37.5°С and ≤ 40.0°С from onset of the disease.
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- Male and female patients aged from 18 to 65 years.
- According to the routine clinical practice, a patient is scheduled to receive the treatment as per one of the following regimens:
- Basic therapy of ARVI1 + Cycloferone®.
- Basic therapy of ARVI1 + Arbidol®.
- Presence of symptoms of ARVI:
- Presence of two and more symptoms of moderate severity or three and more mild symptoms in accordance with the WURSS-21 questionnaire;
- Presence of two and more symptoms of moderate severity or three and more mild symptoms in accordance with the CCQ questionnaire;
- Presence of hyperthermia episodes ≥ 37.5°С and ≤ 40.0°С from onset of the disease.
- Diagnosis as per ICD-10 (primary diagnosis is one of the below diagnoses):
- J00 - Acute nasopharyngitis, rhinitis;
- J02 - Acute pharyngitis;
- J02.8 - Acute pharyngitis caused by other specified pathogens;
- J02.9 - Acute pharyngitis, not otherwise specified;
- J03 - Acute tonsillitis;
- J03.8 - Acute tonsillitis caused by other specified pathogens;
- J02.9 - Acute tonsillitis, not otherwise specified;
- J04 - Acute laryngitis and tracheitis;
- J04.0 - Acute laryngitis;
- J04.1 - Acute tracheitis;
- J04.2 - Acute laryngotracheitis;
- J05 - Acute obstructive laryngitis (croup);
- J05.0 - Acute obstructive laryngitis (croup);
- J06 - Acute infection of the upper respiratory tract of multiple and unspecified localization;
- J06.0 - Acute laryngopharyngitis;
- J06.8 - Other acute infections of the upper respiratory tract of multiple localization;
- J06.9 - Acute infection of the upper respiratory tract, not otherwise specified;
- J20.4 - Acute bronchitis caused by parainfluenza virus;
- J20.5 - Acute bronchitis caused respiratory syncitial virus;
- J20.6 - Acute bronchitis caused by rhinovirus;
- J20.8 - Acute bronchitis caused by other specified agents;
- J20.9 - Acute bronchitis, not otherwise specified;
- J21 - Acute bronchiolitis;
- J21.0 - Acute bronchiolitis caused by respiratory syncytial virus;
- J21.8 - Acute bronchiolitis caused by other specified agents;
- J21.9 - Acute bronchiolitis, not otherwise specified;
- J22 - Acute respiratory infection of lower respiratory tract, not otherwise specified;
- B34.0 - Adenovirus infection, not otherwise specified;
- B34.9 - Viral infection, not otherwise specified;
- B97.0 - Adenovirus infection;
- B97.4 - Respiratory syncytial infection.
- Symptoms of the disease are present for not more than 24 h before inclusion in the study.
- Patient's written consent for participation in the study.
Who cannot join
- The use of other drugs having antiviral and/or immune stimulating and/or immune modulating effect.
- Positive result of SARS-CoV-2 RNA PCR test.
- Suspected novel coronavirus infection COVID-19 in accordance with the Temporary Methodical Recommendations of the MoH of RF on Prophylaxis, Diagnostics and Treatment of Novel Coronavirus Infection (COVID-19) (current version at the time of inclusion of patients).
- Current bacterial infection requiring administration of antibacterial drugs.
- Active non-respiratory viral infection: meningitis, encephalitis, pneumonitis.
- Availability of indications for hospitalization.
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- Chronic pulmonary diseases (asthma, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary emphysema, tracheobronchial dyskinesia, bronchiectasis etc.).
- Pulmonary tuberculosis (active or inactive form).
- Chronic heart failure of functional classes III-IV according to functional classification of the New York Heart Association (NYHA) including instable progressive angina pectoris of functional class IV, uncontrolled arterial hypertension, severe arterial hypotension, severe arrhythmia requiring the treatment with antiarrhythmic drugs of classes Ia, Ib, Ic or III, myocardial infarction, surgeries on the heart and coronary vessels, transient ischemic attack or stroke, pulmonary embolism or deep vein thrombosis.
- Psychic diseases, neuromuscular, neurocognitive disorders, history of epilepsy.
- Decompensated diabetes mellitus.
- Obesity of degree 2-3 (body mass index ≥ 35.0 kg/m2).
- Severe decompensated renal and hepatic diseases including cirrhosis (acute/chronic renal/hepatic failure).
- Thyroid diseases.
- Stomach and duodenum ulcer or other erosive-ulcerative gastrointestinal disorders in exacerbation stage.
- Malabsorption syndrome or other clinically significant gastrointestinal disease (uncorrected vomiting, diarrhea, ulcerative colitis and others).
- Malignant neoplasms.
- Pregnancy, breast feeding.
- Hemoglobinopathy.
- Primary and secondary immunodeficiencies (HIV-infection, use of immunosuppressants, systemic glucocorticoids etc.).
- Contraindications mentioned in the approved instructions for use of the drugs used in the study.
- Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
Clinic Zvezdnaya
Saint Petersburg
Medical center Astarta
Saint Petersburg
Medical Center Energiya Zdoroviy
Saint Petersburg
Medical Center Meily
Saint Petersburg
Medical Center Oris
Saint Petersburg
Medical Center PiterClinica
Saint Petersburg
Medical Center Reavita Med
Saint Petersburg
Medical Center SOGAZ
Saint Petersburg
Research Center Eco-Safety
Saint Petersburg
Сity clinic No. 117
Saint Petersburg
Сity clinic No. 44
Saint Petersburg
Сity clinic No.109
Saint Petersburg
Сity hospital No. 40
Sestroretsk
About this study
Official title: Non-interventional Prospective Study of Safety and Efficacy of the Drug Cycloferone® (NTFF "POLYSAN" Ltd., Russia) in Patients with Acute Respiratory Viral Infection At the Outpatient Stage
The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings.
- Conditions
- Acute Respiratory Viral Infection
- Being tested
- Cycloferone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycloferoneDrug
Also called paracetamol
Cycloferone® is administered according to the instruction for medical use: 600 mg (4 tablets) once daily on day 1, 2, 4, 6 and 8.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Basic therapy of ARVI1 + Cycloferone®. Cycloferone® is administered according to the instruction for medical use: 600 mg (4 tablets) once daily on day 1, 2, 4, 6 and 8. Receives: Drug: Cycloferone | |
| The test group | Basic therapy of ARVI1 + Arbidol®. Arbidol® is administered according to the instruction for medical use: 200 mg (4 capsules) 4 times/day for 5 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average fever duration according to the data of the Patient's Diary
ending of fever is defined as body temperature < 37.0°С for 24 hours and more
Measured: Baseline, up to 9 days
Secondary outcomes (11)
Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)**
*Wisconsin Upper Respiratory Symptom Survey - 21. The WURSS-21 is a valid and reliable self-report research tool incorporating specific symptoms and functional impairments common to Acute upper respiratory infection
**Dynamics of symptom severity according to WURSS-21 scale is assessed using the area under the curve (AUC) at visits 2, 3 and 4. AUC is calculated using the trapezoidal rule. WURSS-21 consists of 21 items (2 questions and 2 domains). Domain of symptoms consists of 10 items: rhinitis, nasal stuffiness, sneezing, sore throat, throat irritation, cough, hoarseness, headache, chest congestion, feeling of fatigue. Domain of abilities consists of 9 items: ability to think clearly, sleep well, breath freely, walk, go upstairs, do physical exercises, fulfil everyday life actions, work not at home, work at home, interact with people, live own private life. The first 20 items are assessed by the 8-point scale (from 0 to 7). The last item is assessed by the 7-point scale (from 0 to
Measured: Baseline, 3 day, 5 day, 9 day
Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4
CCQ (Common Cold Questionnaire)
Measured: Baseline, 3 day, 5 day, 9 day
Time (days) till disappearance of disease symptoms according to WURSS-21 scale.
Wisconsin Upper Respiratory Symptom Survey - 21
Measured: Baseline, 3 day, 5 day, 9 day
Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale.
Wisconsin Upper Respiratory Symptom Survey - 21
Measured: Baseline, 3 day, 5 day, 9 day
Number of patients with symptoms of disease of different severity degree according to CCQ scale.
CCQ (Common Cold Questionnaire)
Measured: Baseline, 3 day, 5 day, 9 day
Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy.
Wisconsin Upper Respiratory Symptom Survey - 21
Measured: Baseline, 3 day, 5 day, 9 day
Frequency of the need to administer the systemic antibacterial therapy
Frequency of the need to administer the systemic antibacterial therapy
Measured: Baseline, 3 day, 5 day, 9 day
Percentage of patients who needed hospitalization
Hospitalization
Measured: Baseline, 3 day, 5 day, 9 day
Average duration of the temporary incapacity period.
Duration of the temporary incapacity period
Measured: Baseline, 3 day, 5 day, 9 day
Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen.
Acute respiratory viral infection (ARVI)
Measured: Baseline, 3 day, 5 day, 9 day
Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1.
Acute respiratory viral infection (ARVI)
Measured: Baseline, 3 day, 5 day, 9 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start20 Sep 2023
- Primary completion20 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Viral InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286254
- Sponsor's protocol ID
- CYCL-NTTF-2023
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Prospective Study of Safety and Efficacy of the Drug Cycloferone® (NTFF "POLYSAN" Ltd., Russia) in Patients with Acute Respiratory Viral Infection At the Outpatient Stage
- ClinicalTrials.gov ID
- NCT06286254
- Acronym / sponsor ID
- CYCL-NTTF-2023
- Conditions
- Acute Respiratory Viral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Feb 2024 (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.
The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | Drug: CycloferoneBasic therapy of ARVI1 + Cycloferone®. Cycloferone® is administered according to the instruction for medical use: 600 mg (4 tablets) once daily on day 1, 2, 4, 6 and 8. |
| The test group | – | –Basic therapy of ARVI1 + Arbidol®. Arbidol® is administered according to the instruction for medical use: 200 mg (4 capsules) 4 times/day for 5 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms of ARVI receiving the therapy at the outpatient stage.
Key inclusion criteria (51 listed)
- Male and female patients aged from 18 to 65 years.
- According to the routine clinical practice, a patient is scheduled to receive the treatment as per one of the following regimens:
- Presence of symptoms of ARVI:
- <!-- -->
- Male and female patients aged from 18 to 65 years.
Key exclusion criteria (22 listed)
- The use of other drugs having antiviral and/or immune stimulating and/or immune modulating effect.
- Positive result of SARS-CoV-2 RNA PCR test.
- Suspected novel coronavirus infection COVID-19 in accordance with the Temporary Methodical Recommendations of the MoH of RF on Prophylaxis, Diagnostics and Treatment of Novel Coronavirus Infection (COVID-19) (current version at the time of inclusion of patients).
- Current bacterial infection requiring administration of antibacterial drugs.
- Active non-respiratory viral infection: meningitis, encephalitis, pneumonitis.
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 |
|---|---|---|
| CycloferoneAlso: paracetamolCycloferone® is administered according to the instruction for medical use: 600 mg (4 tablets) once daily on day 1, 2, 4, 6 and 8. | Drug | The control group |
Primary outcome
Average fever duration according to the data of the Patient's Diary
Time frame: Baseline, up to 9 days
ending of fever is defined as body temperature < 37.0°С for 24 hours and more
11 secondary outcomes
Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire)**
Time frame: Baseline, 3 day, 5 day, 9 day
Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4
Time frame: Baseline, 3 day, 5 day, 9 day
Time (days) till disappearance of disease symptoms according to WURSS-21 scale.
Time frame: Baseline, 3 day, 5 day, 9 day
Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale.
Time frame: Baseline, 3 day, 5 day, 9 day
Number of patients with symptoms of disease of different severity degree according to CCQ scale.
Time frame: Baseline, 3 day, 5 day, 9 day
Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy.
Time frame: Baseline, 3 day, 5 day, 9 day
Frequency of the need to administer the systemic antibacterial therapy
Time frame: Baseline, 3 day, 5 day, 9 day
Percentage of patients who needed hospitalization
Time frame: Baseline, 3 day, 5 day, 9 day
Average duration of the temporary incapacity period.
Time frame: Baseline, 3 day, 5 day, 9 day
Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen.
Time frame: Baseline, 3 day, 5 day, 9 day
Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1.
Time frame: Baseline, 3 day, 5 day, 9 day
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 16 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Viral Infection, run by POLYSAN Scientific & Technological Pharmaceutical Company at 13 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 51 inclusion and 22 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Average fever duration according to the data of the Patient's Diary (time frame: Baseline, up to 9 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 16 Dec 2024.