CTRI/2020/10/028376尚未招募未知
A randomized, multi center, open label, parallel-group, comparative, clinical study to evaluate safety and efficacy of CoviToneâ?¢ as an adjuvant to standard of care compared to standard of care alone in mild to moderate COVID-19 symptomatic adult patients.
Arber Biosciences Pte Ltd0 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
- 未知
- 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.Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab or patient who have tested positive within 5 days of the screening visit
- •2. Patients clinically assigned as mild (Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without evidence of breathlessness or hypoxia)
- •3. Patients clinically assigned as moderate(Pneumonia with no signs of severe disease, respiratory rate >=24 breaths/minute, SpO2 <94% (90%-94%) on room air)
- •4.Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment
- •5. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator.
- •6. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
- •7. Must be willing and able to give informed consent and comply with the study procedures
排除标准
- •1. Patients clinically assigned as having severe COVID-19 disease (Severe Pneumonia (with respiratory rate >=30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock], critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of randomization or during the course of the study)
- •2.Patients with history of or one or more known comorbidities at screening (Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure , Uncontrolled Diabetes Mellitus ,Chronic obstructive pulmonary disease (COPD), Asthma or Interstitial Lung Disease, Malignancy ,Kidney Disease (Serum creatinine > 1.5 times upper limit) ,Liver disease (e.g. Child Pugh score >= B or AST (Aspartate Transaminase) >4 times upper limit)
- •Cardiac conduction delay (QTc > 500 msec) ,Glucose-6-phosphate dehydrogenase (G6PD) deficiency Psoriasis or porphyria ,Other underlying severe diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition)
- •3.In case of patients with symptoms associated with COVID-19 at screening assessment (i.e., one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhoea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 5 days before screening (not applicable for re-treated/relapsed patients).
- •4.History of recent blood donation , Immunodeficiency disease, Allergy, medication or supplement use that influences the immune system. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients , Inability to take oral medication, Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption, ,Concomitant medication/supplement which could affect the study ,Antiviral therapy prior to screening ,Any contraindication to blood sampling
- •Patients allergic to herbal products or any component of the study product
- •6. Female patients who are pregnant or lactating
- •7. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment
- •8. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (e.g. Methotrexate, Cyclosporine etc.)
- •9. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the patient from completing the study.
研究者
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