Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Control Intervention1: ZingiVir H: An ayurvedic herbo mineral antiviral patented and proprietary drug. The antiviral dose is 6 tabs per day ( 500 mg tablets ) in divided doses - 6AM-9Am -12PM-3Pm-6PM-
Sponsors
Pankajakasthuri herbal research foundation
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both sexes aged 18 years and older. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID19 infection confirmed by RT Polymerase chain reaction RT-PCR test PCR positive in sample collected lesser than 96 hours prior to enrollment; Currently hospitalized and requiring medical care for COVID-19 atleast ONE of the following co-morbid risk factor Age above 60 years Documented history of coronary artery disease Heart failure New York Heart Association Class 3 or 4 Hypertension, requiring at least 1 prescription medicine for management. Dyslipidemia, requiring at least 1 prescription medicine for management. Chronic lung disease eg, asthma or chronic obstructive pulmonary disease requiring treatment Documented history of stroke Diabetes mellitus, requiring at least 1 prescription medicine for management Documented chronic kidney disease with an estimated glomerular filtration rate lesser than 30 mL/min, not on dialysis Obesity Class 2 or 3 body mass index greater than 34.9 kg per m2) History of Chronic Kidney disease Oxygen saturation between 90 and 95% with or without supplemental oxygen Willing to cooperate with investigation team on study procedures including Radiographic assessments during the study period.
Exclusion criteria
Exclusion criteria: Any of the following would exclude the subject from participation in the study: Subject or Authorized Representative is unable to provide informed consent Subject is pregnant or breastfeeding ladies Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital Acute Respiratory Distress illness which is defined as the presence of critical signs and symptoms related with the COVID infection as per WHO criteria on severity at the time of enrollment History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study Severe hepatic dysfunction like liver cirrhosis Clinically significant congenital anomaly of the respiratory tract Inability to take oral medication Prolonged QTc-interval in baseline ECG ( >500 ms) Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis Participation in another research study involving an investigational agent within 30 days prior to consent 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic changes in lungs evaluated by Chest computed tomography scan Radiographic changes in brain evaluated by Brain computed tomography scanTimepoint: 0,15,30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants experiencing Treatment-Emergent Adverse Events Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Changes in the CT Chest scan before and after treatment. Changes in the CT Brain scan before and after treatment. Signal variations in the Electro cardio gram (ECG) and Electro Encephalo gram (EEG) before and after treatment. Forced Vital Capacity (FVC) Forced Expiratory Volume in 1 second (FEV1) Timepoint: 0,15,30 days | — |
Countries
India
Contacts
Public ContactDr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation
Outcome results
None listed