Clinical trial NCT06286254: Study of Safety and Efficacy of the Drug Cycloferone in Patients with Acute Respiratory Viral Infection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Viral Infection
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptoms of ARVI receiving the therapy at the outpatient stage.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged from 18 to 65 years.
2. 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®.
3. 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.

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1. Male and female patients aged from 18 to 65 years.
2. 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®.
3. 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.
4. 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.
5. Symptoms of the disease are present for not more than 24 h before inclusion in the study.
6. Patient's written consent for participation in the study.

Exclusion Criteria:

1. The use of other drugs having antiviral and/or immune stimulating and/or immune modulating effect.
2. Positive result of SARS-CoV-2 RNA PCR test.
3. 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).
4. Current bacterial infection requiring administration of antibacterial drugs.
5. Active non-respiratory viral infection: meningitis, encephalitis, pneumonitis.
6. Availability of indications for hospitalization.
7. Chronic pulmonary diseases (asthma, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary emphysema, tracheobronchial dyskinesia, bronchiectasis etc.).
8. Pulmonary tuberculosis (active or inactive form).
9. 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.
10. Psychic diseases, neuromuscular, neurocognitive disorders, history of epilepsy.
11. Decompensated diabetes mellitus.
12. Obesity of degree 2-3 (body mass index ≥ 35.0 kg/m2).
13. Severe decompensated renal and hepatic diseases including cirrhosis (acute/chronic renal/hepatic failure).
14. Thyroid diseases.
15. Stomach and duodenum ulcer or other erosive-ulcerative gastrointestinal disorders in exacerbation stage.
16. Malabsorption syndrome or other clinically significant gastrointestinal disease (uncorrected vomiting, diarrhea, ulcerative colitis and others).
17. Malignant neoplasms.
18. Pregnancy, breast feeding.
19. Hemoglobinopathy.
20. Primary and secondary immunodeficiencies (HIV-infection, use of immunosuppressants, systemic glucocorticoids etc.).
21. Contraindications mentioned in the approved instructions for use of the drugs used in the study.
22. Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.

Primary outcomes:
measure: Average fever duration according to the data of the Patient's Diary
timeFrame: Baseline, up to 9 days
Secondary outcomes:
measure: 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)**
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Time (days) till disappearance of disease symptoms according to WURSS-21 scale.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Number of patients with symptoms of disease of different severity degree according to CCQ scale.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Frequency of the need to administer the systemic antibacterial therapy
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Percentage of patients who needed hospitalization
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: Average duration of the temporary incapacity period.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: 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.
timeFrame: Baseline, 3 day, 5 day, 9 day
measure: 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.
timeFrame: Baseline, 3 day, 5 day, 9 day
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Clinic Zvezdnaya
city: Saint Petersburg
country: Russian Federation
facility: Medical center Astarta
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Energiya Zdoroviy
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Meily
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Oris
city: Saint Petersburg
country: Russian Federation
facility: Medical Center PiterClinica
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Reavita Med
city: Saint Petersburg
country: Russian Federation
facility: Medical Center SOGAZ
city: Saint Petersburg
country: Russian Federation
facility: Research Center Eco-Safety
city: Saint Petersburg
country: Russian Federation
facility: Сity clinic No. 117
city: Saint Petersburg
country: Russian Federation
facility: Сity clinic No. 44
city: Saint Petersburg
country: Russian Federation
facility: Сity clinic No.109
city: Sestroretsk
country: Russian Federation
facility: Сity hospital No. 40
Study officials:
References: