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

NCT04501783 | Completed Phase 3

• 1 other identifier: TL-FVP-t-01
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 10

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)

Conditions

COVID-19

Keywords

SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; 2019-nCoV; 2019 novel coronavirus; Respiratory disease; lung disease

Outcome Measures

Primary Outcomes (2)

• Time to clinical improvement

  To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening

  through Day 28

• Time to viral clearance

  To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling

  through Day 28

Secondary Outcomes (7)

• Rate of clinical improvement at separate time points

  Day 7

• Rate of viral clearance at separate time points

  Days 5 and 7

• Time to body temperature normalization

  through Day 28

• Rate of resolution of lung changes on CT

  Day 14

• Rate of adverse drug reactions (ADR) and serious ADR

  through Day 28

Study Arms (2)

TL-FVP-t (favipiravir) Treatment Arm

EXPERIMENTAL

Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC); Days 2-10: 800 mg BID plus SOC.

Drug: Favipiravir; Drug: standard concomitant therapy

Standard of Care Arm

ACTIVE COMPARATOR

Standard of Care including etiotropic therapy according to MoH of Russian Federation Recomendations for COVID-19 (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine, or mefloquine in recomended regimen) up to10 days

Drug: Standard of care (SOC); Drug: standard concomitant therapy

Interventions

Favipiravir DRUG

TL-FVP-t will be administered orally

Also known as: TL-FVP-t, Koronavir

TL-FVP-t (favipiravir) Treatment Arm

Standard of care (SOC) DRUG

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

Standard of Care Arm

standard concomitant therapy DRUG

Standard of care according to MoH of Russian Federation recomendation for COVID-19

Standard of Care Arm; TL-FVP-t (favipiravir) Treatment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (10)

Medical center LLC "Neuroprofi"

Korolyov, Russia

Location

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

Location

Medical centers JSC "Medsi Group of Companies"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow "City Clinical Hospital №52 of the Moscow City Healthcare Department"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow "City Clinical Hospital №67 n.a. LA Vorokhobova of the Moscow City Healthcare Department"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow "Infectious Diseases Clinical Hospital №1 of the Moscow City Healthcare Department"

Moscow, Russia

Location

Medical center LLC "Medical Center Eco-safety"

Saint Petersburg, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"

Saint Petersburg, Russia

Location

Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"

Voronezh, Russia

Location

State Budgetary Healthcare Institution of the Moscow Region "Zhukovskaya City Clinical Hospital".

Zhukovskiy, Russia

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Lung Diseases

Interventions

favipiravir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 6, 2020
• Study Start: May 20, 2020
• Primary Completion: July 29, 2020
• Study Completion: August 4, 2020
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (10)