Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Bio-Immune as Anti-viral for SARS2 nCoV: 2 grams Bio-Immune powder three times daily in lukewarm water after food by oral route for 30 days.
Intervention2: Covalix Vaccoil as alternate
Sponsors
Leaf BioLab Leaf Research Institute A Unit of Young Naturalist Network
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must be divided into two major groups: A) Controlled Group B) Uncontrolled Group Control Group: Healthy Individuals Proven cases of SARS2 nCoV with or without other health issues like COPD, DM, HTN etc Uncontrolled Group: Asymptomatic patients who are not SARS2 nCoV positive, which can be either those who tested negative or normal public.
Exclusion criteria
Exclusion criteria: 1. Patients who are taking radiation therapy 2. Patients with sepsis, HIV, Autoimmune 3. Patients on ventilator (critical SARS2 nCoV patients, who used any drug in treatment process) 4. Patients below age of 5 years 5. Patients with nerve disorder 6. History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study 7. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 8. Clinically significant congenital anomaly of the respiratory tract 9. Inability to take oral medication 10.Prolonged QTc-interval in baseline ECG ( >500 ms) 11. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis 12. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period. 13. Participation in another research study involving an investigational agent within 30 days prior to consent 14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results 15. Patients not willing to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical cure rate: Time to get a negative status from SARS2 nCoV (defined as viral load of respiratory and serological specimen negative for two consecutive times when tested in an interval of two days)Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Duration of fever and each of the respiratory symptoms 2.Improvement in hematological and laboratory parameters , 3.No of cases Reporting any ADR/AE 4.Number of patients referred. 5.Number of cases that required invasive or non-invasive oxygen therapy during the intervention. 6.Number of cases that progressed to multi- organ failure while under clinical trial. 7. Serological survey of patients after applied of Bio-Immune & Covalix Vaccoil .Timepoint: 35 days | — |
Countries
India
Contacts
Public ContactAMIT DUTTA
Leaf BioLab, Leaf Research Institute (A Unit of Young Naturalist Network)
Outcome results
None listed