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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501783 on ClinicalTrials.gov