COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45173

Dr Jignasha Captain

drmilishah@gmail.com

2020-07-04

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

Covid 19 positive RT-PCR (nasopharyngeal swab) result <br/ >Adults 30 to 60 of both sex <br/ >Mild to Moderately severe disease (NEWS score Less than or equal to 8) <br/ >Patients willing to provide informed consent <br/ >

Requiring ICU admission and or artificial ventilation at the screening <br/ >Any other comorbidity which is with a critical stage at a screening <br/ >Any other condition by which subject proves unfit from investigator perspective <br/ >Chronic constipation for more than 7 days at the time of screening <br/ >Severe stage of disease (NEWS score more than 8) <br/ >Patients with G6PD deficiency <br/ >Pregnant and breastfeeding women <br/ >

2

Bisleri Charitable Trust

30

60

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

Changes in X-ray chest: interstitial pattern. <br/ >Changes in hematological parameters like- blood cell counts (Absolute and differential) <br/ >Changes in oxygenation index: SpO2. <br/ >Changes in serum inflammation parameters like- LDH; CRP; ferritin <br/ >Changes in NEWS (National Early Warning Score) <br/ >Number of days for negative RT-PCR test for Covid 19Timepoint: From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 952, "treatment_name": "Ozone therapy", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]