EUCTR2020-002753-22-ES进行中（未招募）1 期
Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia-A randomized, double blind, placebo- controlled study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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.Adult age: from 18 to 85 years included (at the time of informed consent) of both genders
- •2.Patients with categories 3 to 5 on the ordinal scale
- •3.Patients who meet all of the following criteria 1), 2), 3), and 4) at the time of enrollment
- •1)Patients who tested positive for SARS-COV2 on RT-PCR test from respiratory specimen(s)
- •2)Patients with new lung lesions on chest images (chest x-ray, CT scan, etc.)
- •3)Patients with SpO2 < 94%
- •4)Patients who meet at least 2 of the following symptoms/findings:
- •-Fever of 37.5°C or higher
- •-Respiratory rate = 24/min
- •4.For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug
- •5.Patients who understand the contents of this study and are able to provide written consent by themselves or by legally authorized representative
- •6. During the influenza virus season, if the incidence is above the epidemic threshold, patients with a
- •negative test resul
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Patients who show increased procalcitonin levels (1 ng/ml or higher) before the start of study drug administration and are suspected to have concurrent bacterial infection
- •2.Patients who show abnormal NT-pro BNP levels (400 pg/mL or higher) and are suspected to have concurrent congestive heart failure
- •3.Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
- •4.Patients with renal impairment requiring dialysis
- •5.Patients with disturbed consciousness such as disturbed orientation (except with a nasogastric tube administration)
- •6.Pregnant or possibly pregnant patients and lactating or nursing female patients
- •7.Patients (and their partners) who desire to become pregnant during the study period or who cannot abstain from sex or who will not use contraceptives from the start of favipiravir until 14 days after end of administration
- •8.Male patients whose partner cannot agree to use the contraception method described above (criterion 7)
- •9.Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration
- •10.Patients with hereditary xanthinuria
- •11.Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi
- •12.Patients with a history of gout or on treatment for gout or hyperuricemia
- •13.Patients receiving immunosuppressants (tocilizumab and corticosteroids administration is permitted)
- •14.Other patients judged ineligible by the principal investigator or sub-investigator
- •15.Known allergy to any study medication and its excipients
- •16.Patients on the current treatment or who have been treated during last 7 days with remdesivir
研究者
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