CTRI/2021/02/030986招募中2 期
A phase-II, multi-centre, randomized, open label, two arm, controlled trial of sodium-copper-chlorophyllin given along with treatment of physicianâ??s choice versus treatment of physicianâ??s choice in asymptomatic or mildly symptomatic patients with SARS-CoV-2 Infection (Covid-19).
IDRS Labs Private Limited0 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
- 招募中
- 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
- •Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria:
- •1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen.
- •2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion.
- •3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening.
- •4. Have an oxygen saturation of >94% while breathing ambient air.
- •5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion.
- •6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
排除标准
- •Patients will not be eligible for this study if any of the following in present at the time of study inclusion:
- •1. Have pneumonia confirmed by chest imaging.
- •2. Patients receiving mechanical ventilation or ECMO or who have multiorgan failure.
- •3. Pregnant or lactating females.
- •4. Therapy with an investigational agent within the past 30 days from screening.
- •5. Treatment with any drug having anti-SARS-CoV-2 activity prior to screening including hydroxychloroquine and other antiviral agents.
- •6. Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study.
研究者
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