Conducting Clinical Trials of the Medicine "Rutan Tablets 0.1g" No. 10 in the Complex Therapy of COVID-19

• Status: Completed
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of the registered drug Rutan 0.1 against SARS-CoV-2 in patients with COVID-19.

The main group (30 people) - patients with COVID-19 who are on inpatient treatment who were prescribed the drug Rutan 0.1, 1 tablet 2 times a day for 10 days.

The control group (27 people) - patients with COVID-19 who are hospitalized and received therapy according to the National Temporary Protocol for the management of patients with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Institute of Virology, Ministry of Health of the Republic of Uzbekistan

Criteria

Inclusion Criteria:

1. Providing a signed and dated informed consent form.

2. Declared willingness to comply with all study procedures and availability during the study.

3. Man or woman over the age of 18.

4. Patients with PCR-confirmed COVID-19 with mild/moderate disease. U07.1.

5. Ability to take oral medications and willingness to adhere to the regimen.

6. For women of childbearing potential: use of highly effective contraceptives for at least 1 month before screening and agree to use such a method during study participation and for an additional 4 weeks after the end.

7. For men of reproductive potential: use condoms or other methods to ensure effective contraception with a partner.

8. Agree to adhere to the lifestyle principles throughout the study period.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Severe form of COVID-19 disease. U07.1.

3. Treatment with another investigational drug.

4. Individual intolerance to the drug.

5. The occurrence of any allergic reactions.

6. Weighting of the general state of health of the patient and the transition to a severe form of the disease.