Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection

• Status: Completed
• Trial end date: 2020-04-09
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

Criteria

Inclusion Criteria:

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

2. Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.

3. The first 24 hours after ARVI onset.

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

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

Exclusion Criteria:

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

2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.

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

4. Patients requiring antiviral medication prohibited within the study.

5. Medical history of primary and secondary immunodeficiency.

6. Medical history/suspicion of oncology of any localization (except for benign neoplasms).

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

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

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

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

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

12. 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.

13. Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.

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

15. 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).

16. 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).