CTRI/2020/09/028044招募中4 期
A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19
Windlas Biotech Private Limited3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年9月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Safety Assessments
研究概览
简要总结
This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19.
Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects of ≥18 to 60 years of age both inclusive 2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 3.Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-
- •Scores of 2-4 on the WHO Clinical Progression Scale 4.Time interval between symptoms onset and randomization of no more than 7 days 5.One or more of the following symptoms: Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste 6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.
- •A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
- •Known or suspected hypersensitivity to Artemisinin
- •Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
- •Men who are unwilling to use contraception while receiving investigational product
- •Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
- •Subjects with history of severe renal and hepatic impairment.
- •(creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN)
- •Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
- •Known history of failure to control systemic fungal, bacterial or viral infection
- •Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome
- •Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
- •Subjects for whom ventilator support is required at screening
- •Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
- •Subjects not willing to give their informed consent to participate in the clinical trial
- •According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject
- •Using other experimental drugs or participating in other clinical trials in the prior one month.
结局指标
主要结局
Safety Assessments
时间窗: Day 28
- Adverse events (AEs) during the study
时间窗: Day 28
- Serious adverse events (SAEs) during the study
时间窗: Day 28
次要结局
- Efficacy(-Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale.)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 SubjectsCovid19NCT05004753Mateon Therapeutics120
暂停
不适用
To evaluate efficacy and safety of Respiforb in patients with partly controlled asthmaCTRI/2018/09/015862PSK Pharma LLC140
已完成
4 期
Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)Type 2 DiabetesNCT01541956Novartis Pharmaceuticals3,091
已完成
3 期
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)Hepatitis B, Chronic (CHB)NCT00371761Merck Sharp & Dohme LLC25
尚未招募
4 期
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral MetastasisBreast Cancer Stage IVNCT05860907Fudan University384