FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025336 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On: 23/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Randomized Controlled Trial Of Resveretrol-Copper Or Sodium-Copper-Chlorophyllin Vs Standard Treatment In Mild Covid-19 infection 
Scientific Title of Study   A Phase-III, Open Label, Randomized Controlled Trial Of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment In Asymptomatic Or Mildly Symptomatic Patients With SARS-CoV-2 Infection (Covid-19) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indraneel Mittra 
Designation  Professor Emeritus 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer- Tata Memorial Centre 
Address  Dr. Ernest Borges Chair in Translational Research and Professor Emeritus, Department of Surgical Oncology

Raigarh
MAHARASHTRA
410210
India 
Phone  9769769720  
Fax    
Email  indraneelmittra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vikram Gota 
Designation  Scientific Officer F 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer , Tata Memorial Centre 
Address  Department of Clinical Pharmacology ACTREC, Tata Memorial Centre Sector-22, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7715019117  
Fax    
Email  vikramgota@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vikram Gota 
Designation  Scientific Officer F 
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer Tata Memorial Centre 
Address  Department of Clinical Pharmacology ACTREC, Tata Memorial Centre Sector-22, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7715019117  
Fax    
Email  vikramgota@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Dr. Ernest Borges Marg Parel Mumbai 400012  
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr. Ernest Borges Marg Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vikram Gota  Kasturba Hospital for Infectious Diseases  Department of Critical Care Medicine, Kasturba Hospital for Infectious Diseases, Sane Guruji Marg, Arya nagar, Chinchpokli,Mumbai, Maharashtra-400034
Mumbai
MAHARASHTRA 
7715019117

vikramgota@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital For Infectious Diseases,Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorophyllin tablets  Patients will receive oral Chlorophyllin tablets daily under fasting conditions at a dose of 750 mg OD from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. 
Intervention  Resveratrol-Copper tablets   Patients will receive Resveratrol-Copper tablets (1 tablet 4 times per day) from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. 
Comparator Agent  Standard treatment  Patients in this arm can receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. However, patients in this arm cannot receive Resveratrol -Copper treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Male and Non-pregnant Female
2 Positive reverse-transcriptase–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
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients who suffer clinical deterioration OR viral
persistence at Day 10 from the date of randomization (excluding the date of randomization)
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. 
Day 10 
 
Secondary Outcome  
Outcome  TimePoints 
1 All-cause mortality at 28 days after randomization
2 Overall Survival times in days
3 The proportion of patients with virological positivity
4 The proportion of patients with clinical improvement at day 14 
Day 28
Day 28
Day 10
Day 14 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  

At present, there are no specific antiviral drugs or vaccine against COVID-19 disease for potential therapy on humans. It will be worthwhile testing SARS-CoV-2 positive patients with new molecules i.e. resveretrol-copper and sodium-copper-chlorophyllin which may provide a solution to treat the pathology of COVID-19 with its possible mechanism of action. Research has shown that cfCh released from dying host cells following microbial infection leads to bystander host cell apoptosis and inflammation which is perpetuated in a vicious cycle. It can be broken by administration of R-Cu, which inactivates cfCh released from dying cells leading to amelioration of sepsis which is the end stage of COVID-19 as well as it degrades the SARS-CoV2 RNA through which it may show amelioration in viral load and clinical symptoms which may likely to show improvement in clinical condition. The objectives of this study are to assess whether resveretrol-copper and/or sodium-copper-chlorophyllin will reduce the virological load and reduce 28-day mortality in asymptomatic or mildly symptomatic COVID-19 patients. This study will be carried out in 300 SARS-CoV positive patients randomly assigned in 1:1:1 ratio to resveratrol-copper + standard treatment (Arm 1), sodium copper chlorophyllin + standard treatment (Arm 2) or standard treatment alone (Arm 3). The proportion of ‘Failures’ (persistence of viral load at day 10 or clinical deterioration on or before day 10) will be compared between Arm 1 and Arm 3 & between Arm 2 and Arm 3, using chi-square test and the odds ratio for ‘Failure’ will be computed in the 2 comparisons, with their respective 95% CI. The proportion of deaths (28 days mortality) will be compared between Arm 1 and Arm 2 & between Arm 2 and Arm 3, by chi-square tests and odds ratio for deaths (with their 95% CI) calculated for the 2 comparisons.

 


 
Close