UMIT-1 Trial: Favipiravir & Ribavirin Phase IB A Randomised Phase Ib Study to Determine the Phase II Dose and to Evaluate the Safety and Efficacy of Intravenous (IV) Favipiravir & Ribavirin
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF
研究概览
简要总结
UMIT-1: A Randomised Phase Ib Study to Determine the Phase II dose and to Evaluate the Safety and Efficacy of intravenous (IV) Favipiravir & Ribavirin for the Treatment of CCHF
详细描述
This will be a 2:1 randomised open-label phase I trial of IV Favipiravir and IV Favipiravir plus Ribavirin vs optimised standard of care in CCHF. The phase Ib will be carried out to test the safety and tolerability of IV Favipiravir in hospitalised patients. Following review of safety, tolerability and PK data from evaluated phase I doses, an IV Favipiravir doses will be selected to progress to phase II. virological efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult in-patients (≥18 years) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test.
- •Ability to provide informed consent signed by study patient or legally acceptable representative
- •Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in section 5.4 below) from the first administration of trial treatment, throughout trial treatment and for the duration outlined in trial protocol as well as addition 14 days for women and 7 days for men after the last dose of trial treatment.
- •Severity Grading System (SGS) for CCHF - mild/moderate.
- •Less than or equal to 7 days from onset of CCHF symptoms
排除标准
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate <30 mL/min/1.73 m2)
- •Pregnant or breast feeding
- •Anticipated transfer to another hospital which is not a study site within 72 hours
- •Known Allergy to any study medication
- •Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.
- •Positive COVID-19 PCR
- •Previous intolerance of Favipiravir or Ribavirin
- •Haemoglobinopathies
- •Unstable cardiac diseases within 6 months
- •Any participants deemed not suitable, based on investigators opinion.
- •Patients taking the drugs listed in section 8.11 within 30 days or 5 times the half-life (whichever is longer) of enrolment
研究组 & 干预措施
Cohort 1
6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10, or standard of care.
干预措施: Favipiravir (Drug)
Cohort 2
6 patients will be randomised to starting dose of favipiravir 2600 mg BD (day 1), then 1200mg BD day 2 to 10, or standard of care.
干预措施: Favipiravir (Drug)
Cohort 3
6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10 plus Ribavirin, or standard of care.
干预措施: Favipiravir (Drug)
Cohort 3
6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10 plus Ribavirin, or standard of care.
干预措施: Ribavirin (Drug)
Cohort 4
6 patients will be randomised to starting dose of favipiravir 2600mg BD (day 1), then 1200mg BD day 2 to 10 plus Ribavirin, or standard of care.
干预措施: Favipiravir (Drug)
Cohort 4
6 patients will be randomised to starting dose of favipiravir 2600mg BD (day 1), then 1200mg BD day 2 to 10 plus Ribavirin, or standard of care.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF
时间窗: Up to day 8
Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
To determine the safety and tolerability of multiple doses of IV Favipiravir in combination with Ribavirin in patients with CCHF
时间窗: up to day 8
Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
次要结局
- Pharmacokinetic objective: To characterise the plasma pharmacokinetics of multiple doses of IV Favipiravir and IV Favipiravir in combination with Ribavirin(up to Day 8)
- Virologic objective(Change from baseline over time, up to Day 29, in viral load)
- Clinical objective(Time from randomisation to death (up to day 29))