TCTR20200514001已完成2 期
An Investigation of the Efficacy and Safety of Favipiravir in COVID 19 Patients without Pneumonia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 74 Years（—）
- 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
- •1)Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, airway aspirate, or saliva by RT-PCR test
- •2)Patients without lung lesions on chest images that compatible with pneumonia
- •3)Patients with a fever more than or equal to 37.5 degree celsius or symptoms of COVID-19 (including cough, malaise or fatigue, headache, sore throat, nasal congestion, chill or sweating, muscle or joint pain, chest pain, diarrhea, loss of taste and loss of smell)
- •(4)For premenopausal female patients, patients who have been confirmed to be negative on a urine 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
排除标准
- •(1)Fever (more than or equal to 37.5 degree celsius) more than 10 days after the onset of fever
- •(2)Patients who have the following clinical symptoms 1), 2) and 3)
- •1)SpO2 less than 95% without oxygen therapy
- •2)Respiratory rate more than 24 breath/min
- •3)Blood pressure (SBP/DBP) less than 90/60 mmHg
- •(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 (e.g., 1-3-beta glucan: 30 pg / ml or higher)
- •(5)Patients who show, for example, abnormal NT-pro BNP levels (100 pg/mL or higher etc.) and/or 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 7 days after the end of favipiravir administration
- •(13)Patients with hereditary xanthinuria
- •(14)Patients who have previously ever been diagnosed with hypouricemia (less than 1 mg/dL) or xanthine urinary calculi
- •(15)Patients receiving immunosuppressants
- •(16)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 degree celsius or more) or symptoms of COVID-19.
- •(17)Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection
- •(18)Patients who have previously received favipiravir (T-705a)
- •(19)Other patients judged ineligible by the investigator, sub-investigator, or assigned physician
- •(20)Patients who must take the following medication; pyrazinamide, repaglinide, theophylline, famciclovir and sulindac
- •(21)Female patients who intend to have breastfeeding during starting favipiravir administration and until 7 days after stop favipiravir administration
研究者
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