COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43934

Vikram Gota

vikramgota@gmail.com

2020-05-24

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1 Male and Non-pregnant Female <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 <br/ >7 Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate levels <br/ >

1 Have pneumonia confirmed by chest imaging, OR <br/ >2 Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ >3 Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes.

3

Tata Memorial Centre

18

99

India

Mild disease at enrollment

1: Mild disease at enrollment

300

Proportion of patients who suffer clinical deterioration OR viral <br/ >persistence at Day 10 from the date of randomization (excluding the date of randomization) <br/ >Clinical deterioration will be defined as defined as a 2-point or greater deterioration on a 7-point ordinal scale in every patient measured on each day; until Day 10 from the date of randomization.Timepoint: Day 10

| 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": 1116, "treatment_name": "Resveratrol", "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"}]