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

POLYSAN Scientific & Technological Pharmaceutical Company13 sites in 1 country742 target enrollmentSeptember 20, 2023

ConditionsAcute Respiratory Viral Infection

InterventionsCycloferone

DrugsCycloferone

Overview

Phase: Not Applicable
Intervention: Cycloferone
Conditions: Acute Respiratory Viral Infection
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Enrollment: 742
Locations: 13
Primary Endpoint: Average fever duration according to the data of the Patient's Diary
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 20, 2023

End Date

September 30, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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:

Exclusion Criteria

•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.
•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.

Arms & Interventions

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.

Intervention: Cycloferone

Outcomes

Primary Outcomes

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

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)**(Baseline, 3 day, 5 day, 9 day)
Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4(Baseline, 3 day, 5 day, 9 day)
Time (days) till disappearance of disease symptoms according to WURSS-21 scale.(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.(Baseline, 3 day, 5 day, 9 day)
Number of patients with symptoms of disease of different severity degree according to CCQ scale.(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.(Baseline, 3 day, 5 day, 9 day)
Frequency of the need to administer the systemic antibacterial therapy(Baseline, 3 day, 5 day, 9 day)
Percentage of patients who needed hospitalization(Baseline, 3 day, 5 day, 9 day)
Average duration of the temporary incapacity period.(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.(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.(Baseline, 3 day, 5 day, 9 day)