Randomized Controlled Trial Of Resveretrol-Copper Or Sodium-Copper-Chlorophyllin Vs Standard Treatment In Mild Covid-19 infection with Cancer Patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026515
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and non-pregnant female cancer patients 18 years of age or older.
2. Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen
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
4.Oxygen saturation of >94% while breathing ambient air, if this is measured
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.
6. Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible
7. Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate level.
1.Cancer diagnosis not proven
2. Have pneumonia confirmed by chest imaging, 3. Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air
4.Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 1.All-cause mortality at 28 days after randomization (28-day mortality) <br/ ><br>2.Overall Survival times in days (with any-cause death constituting an event) <br/ ><br>3.The proportion of patients with virological positivity. <br/ ><br>4. Translational, including biomarker-related, research in banked bio-specimens.Timepoint: 1.Day 28 <br/ ><br>2.Day 28 <br/ ><br>3.Day 10 <br/ ><br>4.Day 0,5,10,Discharge