CTRI/2021/02/030887已完成2 期
A Phase II, open label, randomized, two arm, parallel group, multi-center, comparative clinical trial to evaluate the safety and efficacy of oral Eflornithine (NSRT2020ââ??¢) against the standard of care in adult hospitalized patients showing signs and symptoms of moderate COVID-19 infection. - BREATHEAZYââ??¢ Trial 1.1
avin Saxena Research and Technology NSRTPvt Ltd0 个研究点目标入组 208 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
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. Is a Confirmed Case of Moderate COVID-19 infection.
- •2.The patient must exhibit the following criteria:
- •a)SpO2: <94% (range 90-94%) on room air.
- •b)Respiratory Rate: ââ?°Â¥ 24/ minute (range ââ?°Â¥ 24 - 30);
- •3.The patient may show any one or more of the below clinical symptoms:
- •c)Dyspnoea and/or hypoxia
- •4.Male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-65 years of age at time of screening.
- •5.Women of childbearing potential must agree to either abstain or use at least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier).
- •6.Agrees not to participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier).
- •7.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •8.Patients ability in the investigators opinion to comply with the protocol procedures.
排除标准
- •1.Is a Confirmed Case of Mild COVID-19 infection (defined as per ICMR guidelines) without evidence of breathlessness or Hypoxia (normal saturation).
- •2.Is a Confirmed Case of Severe COVID-19 infection (defined as per ICMR guidelines) exhibiting the following signs & symptoms:
- •a)SpO2: <90% (on room air).
- •b)Respiratory Rate: > 30/ minute;
- •c)Chest imaging shows (Chest X ray and portable bed side lung ultrasound):
- •bilateral opacities, not fully explained by effusions, lobar or lung
- •collapse, or nodules.
- •3.Testing positive for HIV, HbsAg and HCV infection.
- •4.Females who are currently pregnant or breastfeeding.
- •5.Has a known allergy or other contraindication to Eflornithine.
- •6.Has received Eflornithine within the last 10 days.
- •7.Has received anti-viral or anti-malarial or anti-bacterial within the last 14 days.
- •8.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN).
- •9.QTc interval ââ?°Â¥ 500ms.
- •10.Recent Myocardial Infarction (within last 6 months).
- •11.Known case of (K/C/O) Congestive heart failure.
- •12.K/C/O Chronic Kidney Disease.
- •13.K/C/O of epilepsy.
- •14.K/C/O active Tuberculosis.
- •15.In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •16.The patient has participated in other clinical trials in the last three months.
- •17.Anticipated transfer to another hospital which is not a study site within 72 hours.
研究者
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