COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56647

Mr Taasin Ahmed Shah

tdcruz@meyer.co.in

2021-06-15

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1.Age -18- 60 years (Both sex) <br/ >2.Confirmed COVID 19 patient with positive RT-PCR <br/ >3.Mild symptomatic patients having no signs of severe disease (NEWS score â?¤6) <br/ >4.Home/ institutional quarantined subjects with no necessity of dedicated hospital admission at the time of screening <br/ >5.Subject willing to provide consent and follow up for study duration <br/ >

1.Patients with autoimmune disease or self-reports HIV or syphilis infection <br/ >2.Subject suffering from disorders where Aspirin is contraindicated and/or as per the discretion of investigator <br/ >3.Proves to be unfit for the study as per the investigatorâ??s discretion <br/ >4.Pregnant or lactating women <br/ >5.Requiring hospital admission at screening <br/ >6.Any other comorbidity which is critical stage at screening which in investigator discretion finds subject not suitable for the trial participation <br/ >

2

Meyer Organics Pvt Ltd

18

60

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

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. <br/ >2.Reduction in elevated levels of inflammatory markers such as CRP; LDH Ferritin and D-Dimer. <br/ >3.Changes in blood oxygen level SPO2Timepoint: Screening day3 day5 and day10

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1883, "treatment_name": "Aspirin+multimineral+multivitamin+promethazine", "treatment_type": "Coagulation modifiers+vitamins and dietary supplements+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]