COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001387-10/PT

TECNIMEDE, Sociedade Técnico-Medicinal, S.A. - Medical Department Dev. Projects

dmed.ct@tecnimede.pt

2022-11-16

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

TECNIMEDE, Sociedade Técnico-Medicinal, S.A.

18

100

Portugal

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

480

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.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": null, "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]