Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Particle Life Sciences Formulation Capsules: Each capsule to be consumed orally twice a day immediately after meals for 10
days
Control Intervention1: Standard Treatment protocol design
Sponsors
Particle Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness. Age more than 18 & less than 65 years of either sex. Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8). Patients with oxygen saturation (SpO2) less than 95%. Respiratory rate is more than 20/min. Pulse rate more than 90/min. Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.
Exclusion criteria
Exclusion criteria: Pregnant women. Breastfeeding women. Requiring ICU admission at screening. Patients above 65 years of age and below 18 Years. Past History of MI, Epileptic episodes. Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening. Asymptomatic patients. Patients unwilling for informed consent. Patients with prolonged QTc interval on ECG. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Participant with any immunosuppressive condition or hematological disease. Participation in any other A.S.U and H protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of disease in SARS-CoV-2. Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/face. Serum levels of CRP, D-Dimer, Ferritin, IL-6 (At baseline and end of the study as per availability). Clinical status expressed in percentage of subjects based on Ordinal Scale for Clinical Improvement. Duration of symptoms in Patients of SARS-CoV-2 measured in days.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in National Early Warning Score Hematological parameters like WBC, Hb and platelet count etc. Requirement of admission to intensive care unit Reduced hospital duration Changes in biochemical parameters such as liver function test and renal function test Global assessment score for overall improvement by Investigator and subject Safety and tolerability of the interventionTimepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study | — |
Countries
India
Contacts
Public ContactDr Sagar Mandlik
Vakratund Hospital
Outcome results
None listed