Coronavirus disease 2019 (COVID-19 pneumonia) MedDRA version: 25.1 Level: LLT Classification code 10066740 Term: Acute respiratory tract infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Favipiravir Tablets 200 mg - Fabiflu
Product Name: Favipiravir
Pharmaceutical Form: Tablet
INN or Proposed INN: FAVIPIRAVIR
Current Sponsor code: 259793-96-9
Concentration unit: mg milligr
Sponsors
TECNIMEDE, Sociedade Técnico-Medicinal, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged >= 18 years. 2. Patient understands and agrees to comply with planned study procedures and provides informed consent prior to undergoing any study procedures. 3. Hospitalized for symptoms associated with non-critical COVID-19 pneumonia with an interval between symptoms onset and randomization preferably until 4 days but no longer than 10 days. 4. Virologic confirmation of SARS-CoV-2 infection within 72 hours of randomization as determined by a valid test on respiratory tract specimens. 5. Category 4 or 5 on the WHO 10-point Ordinal Scale for Clinical Progression at time of randomization (hospitalized, with no oxygen therapy, or with oxygen by mask or nasal prongs). 6. Radiological evidence of lung infiltrates consistent with COVID-19 related pneumonia. 7. Women of childbearing potential must have a negative serum pregnancy test. 8. Female and male patients of childbearing potential must agree to use highly effective methods of birth control during their participation in the study and for 7 days after the last administration of study drug. 9. Able to swallow oral medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 336
Exclusion criteria
Exclusion criteria: 1. Hospitalized in the ICU at time of informed consent. 2. Need for advanced ventilatory or clinical support such as non-invasive ventilation (specifically for COVID-19 or within less than 6 months for other pathologies/comorbidities), high flow oxygen therapy, mechanical ventilation, dialysis, or ECMO. 3. History of hypersensitivity to an antiviral nucleoside-analog drug targeting a viral RNA polymerase. 4. Known hypersensitivity to favipiravir or any of its components. 5. Treatment with chemotherapy and/or radiotherapy within 6 months prior to patient randomization. 6. Known history of gout or under treatment for gout or hyperuricemia, hereditary xanthinuria, or hypouricemia or xanthine calculi of the urinary tract. 7. Severe hepatic impairment (Child-Pugh class C, aspartate transaminase [AST] or alanine aminotransferase [ALT] >3 times the upper limit) or end-stage liver disease. 8. Known chronic renal impairment/failure (estimated glomerular filtration rate [eGFR] <30 mL/min or requiring hemodialysis or continuous ambulatory peritoneal dialysis [CAPD]). 9. Severe chronic cardiovascular disorders (defined for the study as prolonged QT (defined as QTcF=450 msec for men and as QTcF =470 msec for women), left ventricular ejection fraction <30%, chronic heart failure (NYHA class IV), active coronary artery disease (CAD) during the last 3 months, clinically significant arrhythmias, uncontrolled blood pressure). 10. Concurrent participation in another clinical trial. 11. Use of monocloncal antibodies or antivirals for COVID-19 treatment (eg, remdesivir, molnupiravir, nirmatrelvir/ritonavir) or for other concurrent infection (eg, oseltamivir for an influenza virus, lopinavir/ritonavir for Human Immunodeficiency Virus [HIV], etc.) 12. Taking corticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone), immunosuppressive or immunomodulatory drugs (eg, immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers) or any monoclonal antibody treatment indicated for other medical conditions prior to SARS-CoV-2 infection. Note: Treatment of study patients following institutional COVID-19 treatment policies or guidelines, including the use of corticosteroids is permitted. 13. Female patients who are pregnant or breastfeeding. 14. Any condition that, in the opinion of the Investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study. 15. Any concomitant medication that could have any potential clinically significant drug interaction with the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the clinical efficacy of favipiravir plus standard of care (SOC) compared to placebo plus SOC by reduction in clinical deterioration.;Secondary Objective: • To assess the impact of favipiravir in preventing COVID-19 disease progression. • To assess the impact of favipiravir on the duration of hospitalization, intensive care unit (ICU) admission, duration of stay in the ICU, mortality, and other healthcare resource use. • To assess the virologic efficacy of favipiravir. • To assess the safety and tolerability of favipiravir.;Primary end point(s): Proportion of patients hospitalized requiring non-invasive ventilation or high flow oxygen, mechanical ventilation, dialysis, ECMO or who are dead at any time from randomization up to Day 15.;Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated up to day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy To assess the impact of favipiravir in preventing COVID-19 disease progression: • Proportion of patients hospitalized requiring non-invasive ventilation, mechanical ventilation, ECMO, dialysis or who are dead at Day 29 and at Day 90. • Clinical status as assessed with the WHO 10-point Ordinal Scale for Clinical -Progression at Day 8, Day 15 and Day 90. • Change in clinical status as assessed with the WHO 10-point Ordinal Scale for Clinical Progression at Day 8, Day 15 and Day 90 relative to Baseline. • Time to change in 1 or in 2 levels/points of the National Early Warning Score 2 (NEWS2) scoring system up to Day 29. To assess the impact of favipiravir on the duration of hospitalization, ICU admission, duration of stay in the ICU, mortality, and other healthcare resource use: • Duration of hospitalization (days) up to and including Day 90. • Proportion of patients in ICU at Day 8, Day 15, Day 29 and Day 90; Duration of stay in the ICU up to and including Day 90). • Overall survival up to and including Day 90. • Proportion of patients requiring any supplemental oxygen therapy at Day 8, Day 15, Day 29 and Day 90. •Duration of oxygen therapy (days) up to Day 90. •Proportion of patients requiring non-invasive ventilation or high flow oxygen, mechanical ventilation, dialysis or ECMO during hospitalization. • Duration of non-invasive ventilation or high flow oxygen (days) up to Day 90. • Proportion of patients requiring invasive mechanical ventilation or ECMO during hospitalization. • Duration of invasive mechanical ventilation or ECMO (days) up to Day 90. • Proportion of patients requiring dialysis during hospitalization. • Duration of dialysis (days) up to Day 90. To assess the virologic efficacy of favipiravir. • Change from Baseline in quantitative SARS-CoV-2 viral load by RT-PCR at Days 3, 5, 8, 10, 15, and 29. • Proportion of patients with viral clearance at Day 8, Day 10 or Day of Discharge, Day 15, and Day 29. Safety To assess | — |
Countries
Portugal
Contacts
Public ContactMedical Department Dev. Projects
TECNIMEDE, Sociedade Técnico-Medicinal, S.A.
Outcome results
None listed