Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19

Inclusion Criteria:

1. Informed consent form signed.

2. Males and females aged 18-60 years;

3. Diagnosis of coronavirus disease caused by SARS-CoV-2 (COVID-19) in a mild or moderate
form (without respiratory failure).

4. Duration of infection symptoms shall be no more than 6 days before randomization.

5. SARS-CoV-2 infection should be verified by PCR at the screening.

6. Ability to follow the protocol and fulfill all the clinical study procedures.

7. Ability and willingness of the subjects and their sexual partners with retained
childbearing potential to use reliable contraception methods throughout the study and
for 3 months after the treatment completion.

8. Willingness not to take alcohol throughout the study.

Exclusion Criteria:

1. Age < 18 and > 60 years.

2. Any etiotropic therapy of coronavirus SARS-CoV-2 (COVID-19) infection prior to the
study.

3. Moderate infection with respiratory failure, severe or extremely severe SARS-CoV-2
(COVID-19) disease.

4. Respiratory failure (RR > 30/min, SpO2 ≤ 93 %) or the need for mechanical ventilation
at the screening.

5. Decreased level of consciousness (disorientation of place, time and personality),
agitation at the screening.

6. Unstable hemodynamics (systolic BP < 100 mm Hg or diastolic BP < 60 mm Hg) found at
the screening.

7. Subtotal diffuse ground-glass induration of pulmonary tissue and pulmonary
consolidation combined with reticular changes; involvement of ≥ 75 % of lung
parenchyma; hydrothorax (CT findings corresponding to ≥ CT-4 according to Department
of Health of Moscow guidelines).

8. Presence of comorbidities:

1. moderate or severe chronic obstructive pulmonary disease or asthma;

2. severe chronic cardiovascular disorders (arrhythmia or conduction disorders,
implanted pacemaker device, myocardial infarction or unstable angina in the
medical history, heart failure);

3. immunocompromised subjects (HIV, cancer, autoimmune diseases, immunodepressant
therapy);

4. severe obesity (body mass index [BMI] ≥ 40);

5. diabetes mellitus;

6. chronic renal failure;

7. chronic moderate or severe hepatic disorders.

9. Any of the following abnormal laboratory tests at the screening: AST or ALT level >
2.5 x upper normal level (UNL), platelet count < 50х109/L.

10. Any history findings which, in the investigator's opinion, may complicate the
interpretation of the study results or generate an additional risk for the subject due
to his/her participation in the study.

11. More than 2 CT diagnostic procedures within the last 6 months prior to randomization
(except for chest CT no earlier than 4 days prior to enrollment).

12. The subject takes the products significantly inhibiting CYP28С, and administration
those products cannot be interrupted for the study duration.

13. Malabsorption syndrome or another clinically relevant gastrointestinal disease which
may affect the study product absorption (uncontrollable vomiting, diarrhea, ulcerative
colitis, etc.).

14. Pregnancy or breast-feeding; women with probable pregnancy at the screening, those
planning to conceive during the study.

15. Known (from the history) or suspected alcohol or psychotropic drug abuse; medicinal or
illicit drug addiction.

16. Mental disorders including those in the medical history.

17. Condition or disease which, according to the investigator or medical monitor, will
compromise the subject's safety or affect assessment of the study product safety.