Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Component A (AP): Tablet containing Aspirin and Promethazine Hydrochloride
Component B (MV) Multivitamin and multimineral tablet
Along with standard of care as per MoHFW guidelines: Com
Sponsors
Meyer Organics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age -18- 60 years (Both sex) 2.Confirmed COVID 19 patient with positive RT-PCR 3.Mild symptomatic patients having no signs of severe disease (NEWS score �6) 4.Home/ institutional quarantined subjects with no necessity of dedicated hospital admission at the time of screening 5.Subject willing to provide consent and follow up for study duration
Exclusion criteria
Exclusion criteria: 1.Patients with autoimmune disease or self-reports HIV or syphilis infection 2.Subject suffering from disorders where Aspirin is contraindicated and/or as per the discretion of investigator 3.Proves to be unfit for the study as per the investigatorââ?¬•s discretion 4.Pregnant or lactating women 5.Requiring hospital admission at screening 6.Any other comorbidity which is critical stage at screening which in investigator discretion finds subject not suitable for the trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement of clinical symptoms including fever, headache, diarrhea, breathlessness, cough, anosmia, fatigue and myalgia on 10 point VAS scale 0- no symptom and 10-severe symptom. 2.Reduction in elevated levels of inflammatory markers such as CRP, LDH Ferritin and D-Dimer. 3.Changes in blood oxygen level SPO2Timepoint: Screening day3 day5 and day10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Requirement of hospitalization. 2.Requirement of admission to intensive care unit. 3. Tolerability 4. Safety evident by adverse eventsTimepoint: Screening day3 day5 and day10 | — |
Countries
India
Contacts
Public ContactMr Taasin Ahmed Shah
Meyer Organics Pvt. Ltd.
Outcome results
None listed