NCT04521296终止2 期
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2020年9月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- (Part 1) Time to SARS-CoV-2 eradication
研究概览
简要总结
To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 19 as of the signed date in written consent
- •Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
- •Subjects who have symptoms within 7 days or 72 hours after diagnosis
排除标准
- •Subjects who cannot orally administer the investigational products
- •Subjects who need administration of immunosuppressants
- •Subjects who are allergic or sensitive to investigational products or its ingredients
- •Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening
- •Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
结局指标
主要结局
(Part 1) Time to SARS-CoV-2 eradication
时间窗: Up to 28 days
Time to reach undetectable SARS-CoV-2 RNA level
(Part 2) Time to clinical improvement of subjective symptoms
时间窗: Up to 14 days
Clinical improvement of subjective symptoms (days)
次要结局
- (Part 1/2) Time to clinical improvement of subjective symptoms(Up to 28 days)
- (Part 2) Change from baseline of subjective symptom scores(Days 4, 7, 10, 14, 21 and 28)
- (Part 1) Rate of SARS-CoV-2 eradication(Days 4, 7, 10, and 14)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese PatientsNutritional and Metabolic DiseasesMetabolic DiseasesNutrition DisordersOverweightObesityNCT00622765Johnson & Johnson Pharmaceutical Research & Development, L.L.C.321
已完成
3 期
Clinical Study for Patients With Hypertension Associated With DyslipidemiaHypertensionDyslipidemiaNCT01764295Daewoong Pharmaceutical Co. LTD.150
已完成
2 期
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus InfectionHepatitis B, ChronicNCT04129554Janssen Sciences Ireland UC130
已完成
2 期
A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety DisorderPhobic DisordersNCT02432703Janssen Research & Development, LLC150
已完成
1 期
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar LinesGlabellar LinesNCT06212960Daewoong Pharmaceutical Co. LTD.20