CTRI/2022/04/041885尚未招募2 期
A phase II, controlled clinical study designed to evaluate progression to hospital admission after the use of Pimozide as an add on therapy in non-hospitalized patients with mild COVID-19 illness - NI
Dr Rahul Kunkulol0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Confirmed Patients of COVID 19 illness as indicated by a positive rapid antigen test or SARS-CoV-2 RT-PCR test for nasopharyngeal or oropharyngeal, sputum, or lower respiratory tract samples, onlypatients with mild severity will be included. Mild severity will be defined as Upper respiratory tract symptoms and/or fever without shortness of breath or hypoxia (SpO2 above 94% on room air)
- •2.Patients 18 years or older age of either gender
- •3.Body mass index (BMI) between 17.0 kg/m2 to 30.0 kg/m2, inclusive for Patients calculated as (weight in kg) / (height in m)2
- •4.Patient who understands and signs the informed consent form to participate in the study.
- •5.Patient who is willing to be available for the entire study period and to adhere to protocol requirements
- •6.Women of childbearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 14 days following termination of study treatment.
- •Contraception is defined as one of the following:
- •a. Surgically sterile (bilateral tubal ligation for women or vasectomy for men) OR
- •b. Using a condom AND one of the following:
- •i. Combined (estrogen-progesterone) hormonal contraception
- •ii. Progesterone-only hormonal contraception
- •iii. Intrauterine device OR
- •iv. Intrauterine hormone-releasing system
- •Note Patients that are at high risk for hospitalization including obesity, hypertension diabetes, ischemic heart disease, and older age will also be included in the study.
排除标准
- •Exclusion Criteria
- •1.Pregnancy
- •2.Patients who have been involved in any interventional studies in the past 1 year
- •3.Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the investigator(s).
- •4.Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
- •5.Reports a history of clinically significant allergies including food or drug allergies.
- •6. Patient having history of hypersensitivity to Pimozide
- •7.Patient with ongoing treatment of antifungal medication
- •8.Patients not willing to sign informed consent form
- •9.Difficulty in swallowing solids like tablets or capsules.
- •10.Actively using corticosteroids, except topical corticosteroids equivalent to or less than 1% hydrocortisone
- •11.Any other condition, that in the investigatorâ??s judgment, might compromise patient safety or affect study results
研究者
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