Randomized Controlled Trial Of Resveretrol-Copper OR Sodium-Copper-Chlorophyllin Versus Standard Treatment In Severe Covid-19 Cancer Patients.
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026514
- 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
Inclusion Criteria
1.Male and non-pregnant female patients 18 years of age or older.
2.Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen.
3.Pneumonia confirmed by chest imaging
3.Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air
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.
6.Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible.
7.Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels.
Exclusion Criteria
Asymptomatic or only mildly symptomatic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 1. All-cause mortality at 28 days after randomization (28-day mortality) in all 3 arms. <br/ ><br>2. Overall Survival times in days (with any-cause death constituting an event)in all. <br/ ><br>3. The proportion of patients with virological positivity, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days. <br/ ><br>4. The proportion of patients with clinical improvement at day 14 after randomization. <br/ ><br>5.Translational, including biomarker-related, research in banked bio-specimensTimepoint: 1.Day 28 <br/ ><br>2.Day 28 <br/ ><br>3.Day 10 <br/ ><br>4.Day 14 <br/ ><br>5.Day 5,Day 10,discharge