Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: LifeViroTreat Inhalation: Group 1: LifeViroTreat Inhalation Dose: 15 min inhalation
Frequency: Every 4 hour
Duration: 3 to 5 days
+ Standard of Care
Group 2. LifeViroTreat Inhalation
Do
Sponsors
Supreme Industries
Eligibility
Inclusion criteria
Inclusion criteria: 1. RT-PCR positive for nCOVID-19 within last 72 hours 2. Male and female patients with age above 18 years and below 65 years of age. 3. Patient willing to provide informed consent to participate into the trial. 4. Patient able to comply requirement of study and protocol. 5. Patient having SpO2 > 94 %, Respiratory rate < 24/min and temperature < 104 �°F
Exclusion criteria
Exclusion criteria: 1 Known hypersensitivity or idiosyncratic reaction to Chlorine or any of related substance or ingredient of the formulation. 2 Patient having past history of respiratory disorder like COPD, Asthma etc. 3 Patient is on medication before tested nCOVID 19 positive for respiratory disease or disorder (other than viral infection). 4 Patients who are diagnosed and/or on treatment for venous thromboembolism, ischemic heart disease, myocardial infarction, congestive cardiac failure, unexplained vaginal bleeding with suspicion of serious underlying condition, history of breast or cervical cancer, malignant tumor 5 Patient of Hypertension and/or Diabetes who was not on stable treatment in past 3 month. 6 Patient was on immunomodulatory drug 7 Have participated in other clinical study related to nCOVID 19 8 Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial. 9 Known history of Chronic Kidney disease 10 Known history of Chronic Liver disease 11 Nursing mother or pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percentage of patients turning RT-PCR negative (success of treatment) at end of treatment (Day 4 or Day 6). -Percentage of patients require hospitalizationTimepoint: Day 4 Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause MortalityTimepoint: Day 14 Day 28;Average number of Antipyretic dose per patient require in 5 days.Timepoint: Day 6;Change in ARVI symptom scale from baselineTimepoint: Day 2, Day 3, Day 4, Day 5, Day 6;Change in Laboratory Parameter from baseline to End of StudyTimepoint: Day 4 Day 6;Change in ordinal scale from baseline.Timepoint: Day 4 Day 6;Percentage of patient become RT PCR negative on Day 4Timepoint: Day 4;Percentage of patient drop out from the studyTimepoint: Day 6;Percentage of patient on improvement of SpO2 levelTimepoint: Day 2, Day 3, Day 4, Day 5, Day 6;Percentage of patient require antibiotic on day 6Timepoint: Day 6;Percentage of patient require continuation of treatment od Day 6Timepoint: Day 6;Percentage of patient with alleviation of Flu like nonspecific symptomsTimepoint: Day 6;Percentage of patient with alleviation of loss of appetiteTimepoint: Day 6;Percentage of patient with alleviation of Nasal/Throat/Chest specific symptomsTimepoint: Day 6;Percentage of patient withdrawn from treatmentTimepoint: Day 6;Time to alleviate loss of appetite symptomTimepoint: Day 2, Day 3, Day 4, Day 5, Day 6;Time to alleviation of flu like nonspecific symptomsTimepoint: Day 2, Day 3, Day 4, Day 5, Day 6;Time to alleviation of Nasal/Throat/Chest specific symptomsTimepoint: Day 2, Day 3, Day 4, Day 5, Day 6;Time to Normalization of body temperature (from Day 1 to Day 6)Timepoint: Day 2, Day 3, Day 4, Day 5, Day 6 | — |
Countries
India
Contacts
Public ContactDr Nilesh Patel
Panexcell Clinical Lab Pvt Ltd
Outcome results
None listed