Oral VIRAHALT (Novel Immunomodulatory Herbal combination) Compared to standard of care in Subjects with Moderate to Severe COVID-19

Not Applicable

Completed

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/09/028133

Lead Sponsor: K Wellness

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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