NCT04657497已完成3 期
A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 25
- 主要终点
- Time to SARS-CoV-2 negative test
研究概览
简要总结
To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.
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)
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
- •Inpatient or outpatient: Inpatient
- •Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
- •Enrollment in this study within 5 days after onset of symptoms of SARS-CoV-2 infection (COVID-19) (for asymptomatic patients, enrollment in this study within 5 days after collection of the sample that tested positive)
排除标准
- •Receiving oxygen therapy
- •Difficulty in swallowing oral medication
- •History of COVID-19
- •History of vaccination against COVID-19
- •Taking camostat mesilate
研究组 & 干预措施
FOY-305 group
Experimental
Camostat Mesilate tablets 600 mg will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days.
干预措施: FOY-305 (Drug)
Placebo group
Placebo Comparator
Placebo tablets will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to SARS-CoV-2 negative test
时间窗: Up to 14 days
Time to SARS-CoV-2 negative test as assessed by the local laboratory
次要结局
- Time to SARS-CoV-2 negative test(Up to 14 days)
- Proportion of subjects who test negative for SARS-CoV-2(Up to 14 days)
- Ordinal scale for severity(Up to 14 days)
- Proportion of subjects on mechanical ventilator(Up to 14 days)
- Survival status (alive/death)(Up to 14 days)
研究者
研究点 (25)
Loading locations...
相似试验
招募中
2 期
SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 PatientsInfection of Upper Respiratory Tract Caused by 2019-nCoVNCT06042764Sinovac Life Sciences Co., Ltd.150
已完成
2 期
A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African AdultsSARS-CoV-2 InfectionCOVID-19NCT04533399Novavax4,422
终止
3 期
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)COVID-19NCT05780541National Institute of Allergy and Infectious Diseases (NIAID)58
已完成
1 期
REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumoniaCOVID19ARDSNCT04468971Cellenkos, Inc.45
已完成
2 期
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)Coronavirus Disease 2019NCT04448756EMD Serono Research & Development Institute, Inc.149