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Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

Sponsored by Materia Medica Holding

About this trial

Last updated 5 years ago

Study ID

MMH-AN-005

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Yes

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

Purpose of the study: • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.

What are the participation requirements?

Yes

Inclusion Criteria

1. Patients of either gender aged 18-70 years.

2. Diagnosis of acute respiratory viral infection (ARVI) based on medical examination: axillary temperature ≥ 37,8 ° C at examination + non-specific/flu-like symptom score ≥4, nasal/throat/chest symptom score ≥2.

3. The first 24 hours after ARVI onset.

4. Seasonal rise in ARVI incidence.

5. Patients giving their consent to use reliable contraception during the study.

6. Signed patient information sheet (informed consent form).

No

Exclusion Criteria

1. Suspected pneumonia, bacterial infection (including otitis media, sinuitis, urinary tract infection, meningitis, sepsis, etc.), requiring the administration of antibacterial drugs from the first day of the disease.

2. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).

3. Clinical symptoms of severe influenza/ARVI requiring hospitalization.

4. Subjects requiring concurrent antiviral products forbidden by the study.

5. Medical history of primary and secondary immunodeficiency.

6. Oncologic conditions /suspected oncologic conditions.

7. Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.

8. Impaired glucose tolerance, diabetes mellitus.

9. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

10. Allergy/ hypersensitivity to any component of the study drug.

11. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.

12. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.

13. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.

14. Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.

15. Participation in other clinical trials for 3 months prior to enrollment in this study.

16. Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).

17. Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Locations

Location

Status