Randomized Controlled Trial Of Resveretrol-Copper Or Sodium-Copper-Chlorophyllin Vs Standard Treatment In Mild Covid-19 infectio

Phase 3

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/05/025336

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

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

7 Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate levels

Exclusion Criteria

1 Have pneumonia confirmed by chest imaging, OR

2 Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air

3 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
Proportion of patients who suffer clinical deterioration OR viral <br/ ><br>persistence at Day 10 from the date of randomization (excluding the date of randomization) <br/ ><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

Secondary Outcome Measures

Name	Time	Method
1 All-cause mortality at 28 days after randomization <br/ ><br>2 Overall Survival times in days <br/ ><br>3 The proportion of patients with virological positivity <br/ ><br>4 The proportion of patients with clinical improvement at day 14Timepoint: Day 28 <br/ ><br>Day 28 <br/ ><br>Day 10 <br/ ><br>Day 14