EUCTR2020-005214-18-LT进行中（未招募）1 期
An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients without Pneumonia- An open-label randomized controlled study
Vilnius University Hospital Santaros klinikos0 个研究点目标入组 75 人开始时间: 2020年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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)Age: 18 to 74 years (at the time of informed consent)
- •(2)Gender: Male or female
- •(3)Patients who meet all of the following criteria 1), 2), and 3) at the time of enrollment
- •3.1)Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT-PCR test
- •3.2)Patients without new lung lesions on chest images that are compatible with pneumonia
- •3.3)Patients with a fever of 37.5°C or more
- •(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 without assistance, or as appropriate with their assent and consent of their parents
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •(1)Fever (37.5°C) more than 10 days after the onset of fever
- •(2)Patients with SpO2 less than 95% without oxygen therapy
- •(3)Patients who show increased procalcitonin levels before the start of study drug administration and are suspected to have concurrent bacterial infection
- •(4)Patients with suspected concomitant fungal infections prior to initiation of study drug (for example 1-3-ß glucan: 30 pg/ml or higher)
- •(5)Patients who show, for example, abnormal NT-pro BNP levels (100 pg/mL or higher) and are suspected to have concurrent congestive heart failure
- •(6)Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
- •(7)Patients with renal impairment requiring dialysis
- •(8)Patients with disturbed consciousness such as disturbed orientation
- •(9)Pregnant or possibly pregnant patients
- •(10)Female patients who are unable to consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 14 days after the end of favipiravir administration.
- •(11)Male patients whose partner cannot agree to use the contraception method described in (10) above
- •(12)Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration
- •(13)Female patients who intend to breastfeed from start of favipiravir administration until 14 days after discontinuation of favipiravir administration
- •(14)Patients with hereditary xanthinuria
- •(15)Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi
- •(16)Patients with a history of gout or on treatment for gout or hyperuricemia
- •(17)Patients receiving immunosuppressants
- •(18)Patients who have received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 9 days after fever (37.5°C or more).
- •(19)Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection
- •(20)Patients who have previously received favipiravir (T-705a)
- •(21)Other patients judged ineligible by the investigator, sub-investigator, or assigned physician
研究者
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