EUCTR2022-001387-10-PT进行中（未招募）1 期
A Phase 3, Multicenter, Prospective, Placebo-Controlled, Randomized, Double-Blind Study to Assess the Efficacy and Safety of Favipiravir in Non-critical Hospitalized Patients with COVID-19 Pneumonia (PROVIR) - PROVIR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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