Status:
COMPLETED
Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
Lead Sponsor:
R-Pharm
Conditions:
COVID-19
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
Detailed Description
This was an open label, randomized, controlled, multicenter Phase 3 study of TL-FVP-t in outpatients and inpatients with mild to moderate COVID-19. After stratification by the severity of their diseas...
Eligibility Criteria
Inclusion
- Informed consent form signed.
- Males and females aged 18-60 years;
- Diagnosis of coronavirus disease caused by SARS-CoV-2 (COVID-19) in a mild or moderate form (without respiratory failure).
- Duration of infection symptoms shall be no more than 6 days before randomization.
- SARS-CoV-2 infection should be verified by PCR at the screening.
- Ability to follow the protocol and fulfill all the clinical study procedures.
- 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.
- Willingness not to take alcohol throughout the study.
Exclusion
- Age \< 18 and \> 60 years.
- Any etiotropic therapy of coronavirus SARS-CoV-2 (COVID-19) infection prior to the study.
- Moderate infection with respiratory failure, severe or extremely severe SARS-CoV-2 (COVID-19) disease.
- Respiratory failure (RR \> 30/min, SpO2 ≤ 93 %) or the need for mechanical ventilation at the screening.
- Decreased level of consciousness (disorientation of place, time and personality), agitation at the screening.
- Unstable hemodynamics (systolic BP \< 100 mm Hg or diastolic BP \< 60 mm Hg) found at the screening.
- 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).
- Presence of comorbidities:
- moderate or severe chronic obstructive pulmonary disease or asthma;
- severe chronic cardiovascular disorders (arrhythmia or conduction disorders, implanted pacemaker device, myocardial infarction or unstable angina in the medical history, heart failure);
- immunocompromised subjects (HIV, cancer, autoimmune diseases, immunodepressant therapy);
- severe obesity (body mass index \[BMI\] ≥ 40);
- diabetes mellitus;
- chronic renal failure;
- chronic moderate or severe hepatic disorders.
- 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.
- 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.
- 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).
- The subject takes the products significantly inhibiting CYP28С, and administration those products cannot be interrupted for the study duration.
- Malabsorption syndrome or another clinically relevant gastrointestinal disease which may affect the study product absorption (uncontrollable vomiting, diarrhea, ulcerative colitis, etc.).
- Pregnancy or breast-feeding; women with probable pregnancy at the screening, those planning to conceive during the study.
- Known (from the history) or suspected alcohol or psychotropic drug abuse; medicinal or illicit drug addiction.
- Mental disorders including those in the medical history.
- 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.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04501783
Start Date
May 20 2020
End Date
August 4 2020
Last Update
January 20 2023
Active Locations (10)
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1
Medical center LLC "Neuroprofi"
Korolyov, Russia
2
Federal budgetary institution of science "Central Research Institute of Epidemiology" of Russian Federal Supervision Service for Consumer Rights Protection and People's Welfare
Moscow, Russia
3
Medical centers JSC "Medsi Group of Companies"
Moscow, Russia
4
State budgetary institution of health care of the city of Moscow "City Clinical Hospital №52 of the Moscow City Healthcare Department"
Moscow, Russia