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

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ClinicalTrials.gov Identifier: NCT04501783
Recruitment Status : Active, not recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
R-Pharm

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)

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Favipiravir Drug: Standard of care (SOC) Drug: standard concomitant therapy Phase 3

Detailed Description:

This is 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 disease (mild or moderate), age (18-44 or ≥ 45 years) and CT severity subjects will be randomized at a rate of 2:1 to receive either TL-FVP-t + standard concomitant therapy or standard ethiptropic therapy (standard of care - SOC) including standard concomitant therapy. Standard ethiptropic therapy according to MoH of Russian Federation includes umifenovir + intranasal recombinant interferon alpha, hydroxichloroquine, or chloroquine.

The dose regimen will be the following: TL-FVP-t at a dose of 1800 mg BID on the Day 1 followed by 800 mg BID during the next 9 days. The study will include the period of therapy (10 days) and follow-up period (18 days).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : July 29, 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TL-FVP-t (favipiravir) Treatment Arm
Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC); Days 2-10: 800 mg BID plus SOC.
Drug: Favipiravir
TL-FVP-t will be administered orally
Other Names:
  • TL-FVP-t
  • Koronavir

Drug: standard concomitant therapy
Standard of care according to MoH of Russian Federation recomendation for COVID-19

Active Comparator: Standard of Care Arm
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)
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




Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: through Day 28 ]
    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

  2. Time to viral clearance [ Time Frame: through Day 28 ]
    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


Secondary Outcome Measures :
  1. Rate of clinical improvement at separate time points [ Time Frame: Day 7 ]
    To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement

  2. Rate of viral clearance at separate time points [ Time Frame: Days 5 and 7 ]
    To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points

  3. Time to body temperature normalization [ Time Frame: through Day 28 ]
    To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.

  4. Rate of resolution of lung changes on CT [ Time Frame: Day 14 ]
    To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT

  5. Rate of adverse drug reactions (ADR) and serious ADR [ Time Frame: through Day 28 ]
    To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR

  6. Rate of severe ADR [ Time Frame: through Day 28 ]
    To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR

  7. Rate therapy termination due to ADR [ Time Frame: through Day 28 ]
    To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501783


Locations
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Russian Federation
Medical center LLC "Neuroprofi"
Korolev, Russian Federation
Federal budgetary institution of science "Central Research Institute of Epidemiology" of Russian Federal Supervision Service for Consumer Rights Protection and People's Welfare
Moscow, Russian Federation
Medical centers JSC "Medsi Group of Companies"
Moscow, Russian Federation
State budgetary institution of health care of the city of Moscow "City Clinical Hospital №57 of the Moscow City Healthcare Department"
Moscow, Russian Federation
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, Russian Federation
State budgetary institution of health care of the city of Moscow "Infectious Diseases Clinical Hospital №1 of the Moscow City Healthcare Department"
Moscow, Russian Federation
Medical center LLC "Medical Center Eco-safety"
Saint Petersburg, Russian Federation
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg, Russian Federation
Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
Voronezh, Russian Federation
State Budgetary Healthcare Institution of the Moscow Region "Zhukovskaya City Clinical Hospital".
Zhukovskiy, Russian Federation
Sponsors and Collaborators
R-Pharm
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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT04501783    
Other Study ID Numbers: TL-FVP-t-01
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by R-Pharm:
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
2019-nCoV
2019 novel coronavirus
Respiratory disease
lung disease