Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Virulina® along with standard treatment protocol: Dose: 3gm, three times a day
Dosage form: Powder
Route of Administration: Oral
Time of Administration: morning, afternoon and evenin
Sponsors
Natural Solutions
Eligibility
Inclusion criteria
Inclusion criteria: 1. Either male or female of age range 18-70 years. 2. Recent history of contact with Covid-19 positive people and are advised to be quarantined or has symptoms which include cough, fever with or without chills and difficulty in breathing (Time interval between symptoms onset and randomization to be not more than 7 days) 3. Patients with laboratory confirmation of infection with SAARS-CoV-2 by positive RT-PCR (within 48 hrs prior to randomization) Subjects willing to give written informed consent and come for a regular follow up 4. Subjects willing to abide by and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer). 2. Presence of acute hypoxic respiratory failure 3. Requires Intensive care unit (ICU) care for management of ongoing clinical status 4. Severe infection, defined as need for invasive or non- invasive ventilator support 5. Inability to intake or tolerate oral medication 6. Category 6 or 5 based on modified 7-category ordinal scale of clinical status 7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission 8. Pregnant subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until cessation of oral shedding of SAARS-CoV- 2 virus (Time in days from randomization to a negative SAARS-Cov-2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab). Time point-Up to 14 days - Clinical cure based on Clinicianâ??s assessment of symptoms which include cough relief, recovery from fever and difficulty in breathing for the period they are in quarantine. (For those patients who presented with clinical signs and symptoms at baseline).Timepoint: Day 1, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the clinical lab variables Subject global assessment of symptoms Composite of cumulative death (i.e. mortality) for all causes and for specific causes. Necessity of invasive assisted ventilation Necessity of non-invasive assisted ventilation Intensive care unit admission Post-anesthesia care unit admission Hospital admission Medical consultation Home care and isolation time Bed rest time symptoms durationTimepoint: Day 1, Day 7 and Day 14. | — |
Countries
India
Contacts
Public ContactDr Anil Sharma
Pharexcel Consulting
Outcome results
None listed