Randomized Controlled Trial Of Resveretrol-Copper OR Sodium-Copper-Chlorophyllin Versus Standard Treatment In Severe Covid-19
Phase 2
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025337
- 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
2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen
3 Pneumonia confirmed by chest imaging
4 Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air
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.
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: Day 28
- Secondary Outcome Measures
Name Time Method 1 All-cause mortality at 28 days after randomization (28-day mortality) in the 3 arms. <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, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days after randomization. <br/ ><br>4 The proportion of patients with clinical improvement at day 14 after randomization.Timepoint: Day 28 <br/ ><br> <br/ ><br>Day 28 <br/ ><br> <br/ ><br>Day 10 <br/ ><br> <br/ ><br>Day 14 <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>