The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical radiologic changes
研究概览
简要总结
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
详细描述
This open-label trial aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients aged 18-75 years old
- •Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR COVID-19 IgM/IgG rapid test
- •No history of favipiravir or oseltamivir allergy
- •Consented to participate in the trial.
排除标准
- •Pregnant women
- •Breastfeeding mother
- •Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times from baseline level
- •Reduced kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min OR serum creatinine > 2 mg/dL
- •Patients with history of heart failure
- •Tuberculosis infection that was treated with pyrazinamide
- •Asthma that was treated with theophylline
- •Type 2 diabetes that was treated with repaglinid
研究组 & 干预措施
Favipiravir
The favipiravir group received loading dose and maintenance dose of Favipiravir for 2 up to 7 days in addition to standard therapy
干预措施: Favipiravir (Drug)
Oseltamivir
The oseltamivir group was given oseltamivir for 7 days.
干预措施: Oseltamivir 75mg (Drug)
结局指标
主要结局
Clinical radiologic changes
时间窗: 14 days
Changes of lung infiltrate in chest xray AND/OR GGO in chest CT scan after 14 days of follow up period This outcome measured will displayed as improvement/no changes/deterioration of radiologic examination results
Percentage of RT-PCR test convertion
时间窗: 14 days
Convertion of RT-PCR swab result from positive to negative at the end of 14 days study follow up This outcome measured will displayed as convertion OR no conversion
次要结局
- Case Fatality Rate (CFR)(14 days)
- Hospital length of stay (LOS)(14 days)
- Adverse event(14 days)
研究者
dr. Dante Saksono Harbuwono, Sp.PD, PhD
Principal Investigator, Head of Endocrinology Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo National Referral Hospital, Faculty of Medicine Universitas Indonesia
Indonesia University