CTRI/2020/07/026529尚未招募2 期
An open label, randomized, three treatment, three arm, parallel group, investigator initiated, comparative clinical trial to evaluate the safety and efficacy of Eflornithine against the standard of care in human adult hospitalized COVID-19 patients
Dr Abhay Vispute Shantaram0 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. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility.
- •2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment.
- •3. Illness or condition of any duration, and at least one of the following:
- •- Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device.
- •- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- •- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR
- •- Requiring supplemental oxygen, OR
- •- Requiring mechanical ventilation.
- •4. 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).
- •5. Agrees to not 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).
- •6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures.
- •7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required.
排除标准
- •1. Testing positive for HIV, HbsAg and HCV infection.
- •2. Females who are currently pregnant or breastfeeding.
- •3. Allergy or other contraindication to one of the investigational products.
- •4. Has received Eflornithine within the last 10 days.
- •5. Has received anti-viral, anti-malarial or anti-bacterial within the last 14
- •6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST)
- •> 5 X upper limit of normal (ULN).
- •7. QTc interval >= 500ms.
- •8. Recent Myocardial Infarction (within last 6 months).
- •9. Known case of (K/C/O) Congestive heart failure.
- •10. K/C/O Chronic Kidney Disease.
- •11. K/C/O active Tuberculosis.
- •12. History of drug or alcohol dependence in the past 6 months.
- •13. 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.
- •14. Anticipated transfer to another hospital which is not a study site within
- •15. K/C/O of epilepsy.
研究者
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