COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45580

VIKRAM GOTA

vikramgota@gmail.com

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Male and non-pregnant female patients 18 years of age or older. <br/ >2.Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen. <br/ >3.Pneumonia confirmed by chest imaging <br/ >3.Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ >4.Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) 5.Abnormalities in any of these parameters. <br/ >6.Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible. <br/ >7.Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels. <br/ >

Asymptomatic or only mildly symptomatic

3

Tata Memorial Centre

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

200

The time to clinical improvement; defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.Timepoint: 10 Days

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "", "treatment_id": 278, "treatment_name": "Chlorophyllin", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1117, "treatment_name": "Resveratrol-copper", "treatment_type": "Nutrition", "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"}]