NCT04940871终止2 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Favipiravir-HU Compared to Placebo as add-on Therapy to Standard of Care in Asymptomatic to Mild Severity COVID-19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- PRIM1_ the percentage of virus copy number
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between the ages of 18 and 65 years.
- •Patients with PCR confirmed SARS-CoV-2 infection
- •Asymptomatic or have mild only symptoms and symptoms are onset less than 5 days
- •Signed Informed Consent Form and Patient Information Leaflet
排除标准
- •Pregnant or possibly pregnant patients or lactating females
- •Patients have moderate to severe or immediately life-threatening COVID-19
- •Major risk factor onset (Obesity, Diabetes, COPD, Hypertension)
- •Patients with SpO2 less than 95% without oxygen therapy
- •Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
- •Patients with renal impairment requiring dialysis
- •Patients with disturbed consciousness such as disturbed orientation
- •Female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation
- •Male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm in 90 days after the start of favipiravir administration.
- •Patients with hereditary xanthinuria
- •Patient with severe uncontrolled hyperuricaemia
- •Patients receiving immunosuppressants
- •Patients who 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 72 hours or Patients who receive forbidden concomitant medication
- •Any medical condition that the examining physician deems unsuitable for the patient to participate in the study
研究组 & 干预措施
Favipiravir HU + SOC
Experimental
Favipiravir HU + SOC
干预措施: Favipiravir HU 200 mg hard capsules (Drug)
Placebo HU + SOC
Placebo Comparator
Placebo HU + SOC
干预措施: Placebo HU (Drug)
结局指标
主要结局
PRIM1_ the percentage of virus copy number
时间窗: 5 months
The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
次要结局
- SEC1_mortality rate(6 months)
- SEC3_ intensive care(6 months)
- SEC5_ invasive respiratory support(6 months)
- SEC4_non-invasive respiratory support(6 months)
- SEC6_ Acute Respiratory Distress Syndrome(6 months)
- SEC2_respiratory failure(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant RecipientsCytomegalovirus InfectionsNCT00411645Shire681
Unknown
4 期
Favipiravir in Hospitalized COVID-19 PatientsCOVID-19NCT04359615Shahid Beheshti University of Medical Sciences40
已完成
1 期
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of SH229 in Patients With HCV InfectionHCV InfectionNCT03588923Nanjing Sanhome Pharmaceutical, Co., Ltd.30
已完成
2 期
Oral Favipiravir Compared to Placebo in Subjects With Mild COVID-19Sars-CoV2COVID-19NCT04346628Stanford University149
已完成
2 期
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes PatientsDiabetes Mellitus, Type 2NCT00328172Boehringer Ingelheim302