CTRI/2021/06/034404已完成2 期
A Phase 2 evaluation of the safety and efficacy of homoeopathic remedy EpiphaniQ in adult patients with mild to moderate COVID-19: Randomized, open label, controlled, multicenter trial
EpiphaniQ LLP0 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
- 已完成
- 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
- •Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or Rapid Antigen Test as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomization; OR PCR positive in sample collected = 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.)
- •2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures.
- •3. Male or non-pregnant female adult =18 years of age at time of enrolment.
- •4. For mild cases subjects without evidence of breathlessness or Hypoxia (normal saturation)
- •5. For moderate cases Illness with =12 days duration, and at least one of the following: i. Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment (chest x-ray, CT scan, lung ultrasound, and etc.), OR ii. Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 90 to = 93% on room air, OR iii. Requiring supplemental oxygen.
- •6. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study.
- •7. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study.
- •8. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.
排除标准
- •A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- •1. Physician makes a decision that trial involvement is not in patient’s best interest, or there is any condition that does not allow the protocol to be followed safely.
- •2. Patient already in, or has already been in, another clinical trial of an experimental treatment for COVID-19
- •3. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline.
- •4. Known medical history of allergy to Zn
- •5. Severe hepatic impairment defined as Child C liver disease.
- •6. eGFR = 30 mL/min/1.73 m2 (defined using CKD-EPI SCr formula)
- •7. History of any organ transplant which requires active immunosuppressive treatment which can interfere with kidney function
- •8. If a patient required cardiopulmonary resuscitation (CPR) within 14 days
- •9. Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment
- •10. Patients with a known or suspected history of oxalate nephropathy or hyperoxaluria, scurvy, chronic iron overload, G-6PD deficiency
- •11. Patients with known or suspected history of cardiovascular disease and LVEF below 30%
- •12. Patient not ready to discontinue the use of multivitamin and Zinc formulations which in the opinion of investigator may interfere with the study.
- •13. Any patient which in the opinion of the principal investigator may worsen in next 72 hours.
研究者
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