Study of Safety and Efficacy of the Drug Cycloferone in Patients with Acute Respiratory Viral Infection

NCT06286254 | Completed

• 1 other identifier: CYCL-NTTF-2023
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• 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

  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)**

  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

Study Arms (2)

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.

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.

Interventions

Cycloferone DRUG

Cycloferone® is administered according to the instruction for medical use: 600 mg (4 tablets) once daily on day 1, 2, 4, 6 and 8.

Also known as: paracetamol

The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptoms of ARVI receiving the therapy at the outpatient stage.

You may qualify if:

• 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.
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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;

You may not qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (13)

Clinic Zvezdnaya

Saint Petersburg, Russia

Location

Medical center Astarta

Saint Petersburg, Russia

Location

Medical Center Energiya Zdoroviy

Saint Petersburg, Russia

Location

Medical Center Meily

Saint Petersburg, Russia

Location

Medical Center Oris

Saint Petersburg, Russia

Location

Medical Center PiterClinica

Saint Petersburg, Russia

Location

Medical Center Reavita Med

Saint Petersburg, Russia

Location

Medical Center SOGAZ

Saint Petersburg, Russia

Location

Research Center Eco-Safety

Saint Petersburg, Russia

Location

Сity clinic No. 117

Saint Petersburg, Russia

Location

Сity clinic No. 44

Saint Petersburg, Russia

Location

Сity clinic No.109

Saint Petersburg, Russia

Location

Сity hospital No. 40

Sestroretsk, Russia

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: September 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: September 30, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13)