A multi-centre, randomized, open label, two arm, controlled trial of SHIRO KLOMAN given along with treatment of physician’s choice versus treatment of Conventional Covid Protocol in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 cases
研究概览
简要总结
The novel coronavirus Covid-19 has caused a massive pandemic with large number of fatalities inmany countries and is shortly expected to reach the devastating levels of the1918 influenza pandemic (1). No proven effective treatments have yet beendiscovered to treat the viral pneumonia caused by Covid-19, although a fewdrugs have shown some promise. Covid-19 is caused by SARS-CoV-2 virus which isan enveloped positive sense RNA virus with an unusually large RNA genome. Other drugs active against SARS-CoV-2 are actively studied,such as protease inhibitors. But drugs with distinct and varied mechanisms ofaction are needed to propose efficient drug combinations. Here we propose aninnovative approach based on the use of the saponin drug glycyrrhizin, which webelieve can be useful to combat the virus infection and to treat the associatedrespiratory symptoms. We searched for a drug that could not only inhibit viralreplication but also interfere with the entry of the virus into cells. On theone hand, we reasoned that an amphiphilic compound like a saponin couldinterfere with the virus entry into cells, owing to the well-known membraneeffects of this class of compounds. On the other hand, we considered that atarget associated to “danger-signals†in cells, like HMGB1, could be a usefulto trigger an immune response. At present, there are no specific antiviral drugs orvaccine against COVID-19 infection for potential therapy of humans. Indesperate times like today’s, it will be worthwhile testing – SHIRO KLOMAN assupplimentary treatment for the corona virus infected patients.
SHIRO KLOMAN can be easily combined with manytypes of drugs, either to promote solubilization and bioavailability of theco-transported product as discussed above, or to complement its mechanism ofaction leading to synergistic effects in some cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
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.
结局指标
主要结局
To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 cases
时间窗: Screening,Baseline,3rd Day,8th day15th day
次要结局
- 1.Percentage of patients with negative SARS-CoV-2 on nasal or throat swab(Screening,Baseline,3rd Day8th day15th day)
