NCT04818320已完成3 期
Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial
Penang Hospital, Malaysia1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Need for oxygen supplement
研究概览
简要总结
The study aims to investigate the efficacy of favipiravir in high-risk COVID-19 patients. The study population includes symptomatic mild-to-moderate COVID-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. The study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible to be included in the study only if they fulfil ALL the following criteria:
- •RT-PCR confirmed COVID-19 cases
- •Aged 50 years and above, AND have one or more co-morbidities
- •Within the first 7 days of illness (from symptom onset)
- •Mild to moderate clinical severity
排除标准
- •Asymptomatic stage 1 patients
- •Patients with SpO2 less than 95% without oxygen therapy
- •Patients who needs oxygen supplements
- •Patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study
- •Patients with congestive heart failure
- •Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
- •Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 30 ml/min) at the time of screening.
- •Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
- •Pregnant or nursing women or women planning pregnancy.
- •Female patients who cannot 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 7 days after the end of favipiravir administration
- •Male patients whose partner cannot agree to use the contraception method described in (9)
- •Patients with a history of gout or on treatment for gout or hyperuricemia
- •Patients receiving immunosuppressants
- •Patients who received interferon or drugs with reported antiviral activity against COVID-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness.
- •Patients in whom this episode of infection is a recurrence or reinfection of COVID-19 infection
- •Patients who have previously received favipiravir
- •Patients who are not able to provide written consent by themselves
- •Other patients judged ineligible by the principal investigator or sub-investigator
研究组 & 干预措施
Favipiravir
Experimental
Favipiravir treatment group (with standard of care),
干预措施: Favipiravir (Drug)
结局指标
主要结局
Need for oxygen supplement
时间窗: Day of discharge/day 28 of treatment (if still hospitalized)
Drop in SPO2 in room air to \<95% or requiring supplemental oxygen to maintain SPO2≥95%
次要结局
- Changes in the length of ICU stay(Day of discharge/day 28 of treatment (if still hospitalized))
- Changes in in-hospital mortality rate(Day of discharge/day 28 of treatment (if still hospitalized))
- Difference in the number of patients admitted to ICU(Day of discharge/day 28 of treatment (if still hospitalized))
- Difference in the number of patients requiring mechanical ventilation(Day of discharge/day 28 of treatment (if still hospitalized))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy of Faviprevir in COVID-19 TreatmentCOVIDNCT04351295Tanta University92
Unknown
2 期
Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of BangladeshCOVID-19Favipiravir (Favipira)NCT04402203Bangladesh Medical Research Council (BMRC)50
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 studyPatients diagnosed with COVID-19 by positive PCR for SARS-COV2MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2020-002753-22-ESFerrer Internacional, S.A.100
已完成
不适用
Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.SARS-CoV InfectionCovid19NCT04885452ANRS, Emerging Infectious Diseases756
已完成
2 期
Favipiravir vs Hydroxychloroquine vs Control in COVID -19SARS-CoV 2COVID-19NCT04387760Royal College of Surgeons in Ireland - Medical University of Bahrain150