Multicenter, double-blind, placebo-controlled, maximum 10 days administration study to evaluate the efficacy and safety of TADIOS as an adjuvant therapy in patients diagnosed with mild to moderate COVID-19

Helixmith Co Ltd6 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年3月16日最近更新: 2021年3月12日

试验速览

阶段: 不适用
状态: 招募中
发起方: Helixmith Co Ltd
入组人数: 100
试验地点: 6
主要终点: (2)Clinical measurements-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

100 patients diagnosed with COVID-19 by RT-PCR will be randomized in a ratio of 1:1 into TADIOS group and placebo group to evaluate efficacy and safety after intake over 10 days.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•1.Male or Female, aged between 18 to 65 years (both inclusive) 2.Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
•3.Patients who are hospitalized into designated hospital for COVID 19 treatment 4.Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19 5.Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.
•a) Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache.
•The elderly may present with atypical symptoms.
•These patients do not have any signs of dehydration, sepsis or shortness of breath.
•b) Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects).
•6.Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study 7.Those who can comply with the requirements and processes in the clinical study 8.Women of childbearing age must be negative to urine pregnancy test during screening.

排除标准

•1.Patients with severe COVID-19 2.Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigatorâ€™s judgment 3.Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding 4.Patients with cardiovascular, liver, and kidney disease 5.Self-reported patients being a recipient of immunosuppressive therapy 6.Self-reported patients who are allergic to this dietary supplements 7.Patients taking a health functional food or medicine that may affect the bodyâ€™s antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit 8.Patients who participated in another clinical trial within 1 month before screening 9.Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study 10.Patients consuming any herbal medicine 11.Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes).
•Menopause refers to 1 year of no menstruation.