A Prospective, Multicenter, Randomized, Open-Label, Proof-of-Concept (PoC) Study to Evaluate the Efficacy and Safety of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19) - START (Siddha Treatment Accelerating Recovery from SARS-CoV-2 Test)

Eminentlabs Business Solutions Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

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.Males and females aged 18 to 75 years, both inclusive
•2.Have laboratory confirmed COVID-19 disease
•3.Asymptomatic patients (who are positive for SARS CoV-2 and with no symptoms) or meets clinical features of the following grades of severity (Appendix II):
•a.Group 1: Suspect and confirmed cases clinically assigned as mild and very mild
•Clinical criteria: Cases presenting with fever and/or upper respiratory tract illness (Influenza Like Illness, ILI).
•b.Group 2: Suspect and confirmed cases clinically assigned as moderate
•Clinical criteria: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%-94%).
•4.Agrees to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered:
•a.Using double barrier contraception,
•b.or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant
•Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception.
•5.Patients or their legal representatives have personally signed and dated the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his/her normal medical care
•6.Patients willing to adhere and comply with the protocol related procedures
•7.Patients willing to take Siddha drug regimen for COVID-19
•8.Agrees not to participate in other clinical studies within 30 days after the last administration of the study drug

排除标准

•1.Patients with other viral pneumonia
•2.Patients with severe or critical COVID-19 disease
•3.Patients who have taken antibiotics/antivirals in the past 1 week
•4.Patients with history of asthma, chronic obstructive pulmonary disease or any other chronic lung disease
•5.Patients with any active malignancy
•6.Patients who have received organ transplantation in the past 6 months or planning surgery
•7.Patients who cannot take food or drugs orally
•8.Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption
•9.Patients who have severe underlying diseases that affects survival, including blood diseases, dyscrasia, active bleeding, severe malnutrition, etc
•10.Patients with uncontrolled blood pressure (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg) or uncontrolled diabetes (HbA1C >7%)
•11.Women patients who are pregnant or lactating, or patients (including male patients) having a pregnancy plan (including plans for sperm donation or egg donation)
•12.Patients with allergic constitution, or patients allergic to investigational products
•13.Patients positive for human immunodeficiency virus, Hepatitis B and Hepatitis C at screening
•14.Patients whose alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal
•15.Patients requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT)
•16.Critical patients with life expectancy <48 hours
•17.Patients who are not suitable to participate in the study based on the investigatorâ??s judgement
•18.Patients who have participated in any clinical trial 30 days prior to screening
•19.Clinically significant laboratory findings at screening

研究者

发起方

Eminentlabs Business Solutions Pvt Ltd

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