CTRI/2021/09/036100尚未招募3 期
A multi-centre, randomized, open label, two arm, controlled trial of SHIRO KLOMAN given along with treatment of physicianâ??s choice versus treatment of Conventional Covid Protocol in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19). - SHIRO KLOMA
Bindi Prashant Shah0 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
- 3 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
- •Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen.
- •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.
- •Have an oxygen saturation of >94% while breathing ambient air, if this is measured.
- •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.
- •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
- •Have pneumonia confirmed by chest imaging.
- •Patients receiving mechanical ventilation or ECMO or who have multiorgan failure.
- •Pregnant or lactating females.
- •Therapy with an investigational agent within the past 30 days from screening.
- •Treatment with any agent with anti-SARS-CoV-2 activity prior to screening.
- •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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