COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43940

Vikram Gota

vikramgota@gmail.com

2020-05-24

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1 Male and non-pregnant female patients <br/ >2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ >3 Pneumonia confirmed by chest imaging <br/ >4 Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ >5 Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (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, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels

Asymptomatic or only mildly symptomatic

3

Tata Memorial Centre

18

99

India

Moderate/severe disease at enrollment

4: Moderate/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: Day 28

| 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": 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"}]