Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: VIRANORM plus Standard of Care (SOC): Oral VIRANORM (Ayurvedic Proprietary Medicine) plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government o
Sponsors
LK Wellness
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must be >=18 years and 2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures 3. Able to adhere to the study visit schedule and other protocol requirements 4. Asymptomatic or Mild Symptomatic PCR positive COVID-19 infection with outpatient/in-patient management as decided by the treating physician 5. Early warning score for 2019-nCoV infected patients 6. Females of childbearing potential must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe 7. Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
Exclusion criteria
Exclusion criteria: 1. Requirement for oxygen administration 2. Shortness of breath in resting position 3. Creatinine > 2.0 mg/dl 4. Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding). 5. Women during pregnancy and lactation 6. Participation in other clinical trials or observation period of competing trials 7. Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). 8. Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). 9. Physician decision that involvement in the study is not in the patient´s best interest 10. History of alcohol or drug abuse in the previous two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in disease manifestation in asymptomatic patients Difference in time to resolution of clinical signs and symptoms of mild COVID-19 Proportion of patients with negative COVID-19 PCR test at day 21 in per protocol population Difference between VIRANORM - and placebo treated patients on an ordinal outcome scale until Day 21 (death, admission to intensive care, hospitalization, duration of hospitalization, continuing disease, recovered) Timepoint: Enrolment Day 3 Day 7 Day 14 Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| COVID-19 antibodies and clinical immunological markersTimepoint: Day 14 Day 21 | — |
Countries
India
Contacts
Public ContactDr Padmanaban KG
LK Wellness
Outcome results
None listed