An Open-label, Prospective, Randomized, Clinical Trial to Compare the Efficacy and Safety of VIRAHALTÂ® Plus Standard of Care with Standard of Care Alone for the Treatment of Moderate to Severe COVID-19 Infection - VIRA 1

K Wellness0 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

暂无简介。

•1. Patients with laboratory-confirmed (PCR) COVID-19 infection
•2. Patients with moderate to severe COVID-19 infection (Early warning score >=5)
•3. Hospitalized patients in clinical centres
•4. Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity
•5. Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above >= 36.6â?°C axillary route, >= 37.2Â°C oral route or >= 37.8 Â°C rectal route), dyspnoea, cough and SpO2 <96%
•6. Patients aged >=18 years, both genders
•7. Patients or LAR able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness

•1. Patients not COVID-19 PCR positive
•2. Patients with mild COVID-19 infection
•3. Patients who are study subjects in another clinical study for another investigational agent for COVID-19
•4. Patients with malignant disease and who are treated for malignant diseases in the last 5 years
•5. Patients with severe liver and kidney insufficiency (Hepatic enzymes (AST, ALT, ALP): 6. More than three times normal at baseline will be excluded. Bilirubin: More than 2 at baseline will be excluded. GFR: Less than 60 at baseline will be excluded)
•7. Patients who are receiving therapy with another experimental immunomodulatory or immunosuppressive agent
•8. Patients aged < 18; female patients who are pregnant or breastfeeding
•9. Known allergy to study nutraceutical or any component thereof

发起方

K Wellness