COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45584

VIKRAM GOTA

vikramgota@gmail.com

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Male and non-pregnant female cancer patients 18 years of age or older. <br/ >2. Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ >3. Either asymptomatic or have only mild symptoms ((cough and/or fever and/or sore throat and/or other upper respiratory symptoms) at the time of study inclusion <br/ >4.Oxygen saturation of >94% while breathing ambient air, if this is measured <br/ >5.Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) 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, should have normal values of pH, PO2, PCO2 and bicarbonate level.

1.Cancer diagnosis not proven <br/ >2. Have pneumonia confirmed by chest imaging, 3. Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ >4.Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes. <br/ > <br/ >

3

Tata Memorial Centre

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

300

the proportion of patients who suffer clinical deterioration OR viral persistence at Day 10 from the date of randomization (excluding the date of randomization).Timepoint: 10 Days

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

Phase 3

[{"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"}]