Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
NCT04501783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2023-01-20
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)
Conditions
Interventions
- DRUG
-
Favipiravir
TL-FVP-t will be administered orally
- DRUG
-
Standard of care (SOC)
SOC will include standard etiotropic therapy (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine) according to MoH of Russian Federation recomendations for COVID-19
- DRUG
-
standard concomitant therapy
Standard of care according to MoH of Russian Federation recomendation for COVID-19
Sponsors & Collaborators
-
R-Pharm
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-20
- Primary Completion
- 2020-07-29
- Completion
- 2020-08-04
Countries
- Russia
Study Locations
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