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CTRI Number  CTRI/2020/07/026514 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 13/07/2020
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 Versus Standard Treatment In Severe Covid-19 Cancer Patients. 
Scientific Title of Study   A Phase-II, Open Label, Randomized Controlled Trial of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment in Cancer patients with SARS-CoV-2 Infection who are Symptomatic Or have Pneumonia for 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  Pankaj Chaturvedi 
Designation  Professor 
Affiliation  Tata Memorial Hospital,Mumbai 
Address  Thirteenth floor, Department of Head and Neck Surgery, Tata Memorial Hospital, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400012
India 
Phone  9869486912  
Fax    
Email  chaturvedi.pankaj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VIKRAM GOTA 
Designation  Scientific Officer F 
Affiliation  ACTREC, Tata Memorial Centre 
Address  Room No.102,Khanolkar Shidhika, Department of Clinical Pharmacology, ACTREC,Sector No.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  Professor 
Affiliation  ACTREC, Tata Memorial Centre 
Address  Room No.102,Khanolkar Shidhika, Department of Clinical Pharmacology, ACTREC,Sector No.22,Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7715019117  
Fax    
Email  vikramgota@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. Ernes Borges Road, Parel West, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 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 
Pankaj Chaturvedi  Tata Memorial Hospital  Thirteenth Floor, Department of Head and Neck Surgery, Tata Memorial Hospital, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
9869486912

chaturvedi.pankaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional ethics committee II   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorophyllin tablets   Patients will be administered orally, tablets of chlorophyllin, 1 tablet of 750 mg once every day, on empty stomach in the morning, from the date of randomization till the day of discharge, or death, whichever is earlier. They will also receive the Standard Treatment . 
Intervention  Resveratrol-Copper tablets   Patients will be administered orally, tablets of R-Cu containing 5.6 mg of Resveratrol and 560 ng of copper, 1 tablet once every 6 hours, from the date of randomization till the day of discharge, or death, whichever is earlier. They will also receive the Standard Treatment  
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. The treatment proptocol will be in sync with the emerging scientific evidence and evolving national guidelines  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male and non-pregnant female patients 18 years of age or older.
2.Positive reverse-transcriptase–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.
 
 
ExclusionCriteria 
Details  Asymptomatic or only mildly symptomatic 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The time to clinical improvement, defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.   10 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. All-cause mortality at 28 days after randomization (28-day mortality) in all 3 arms.
2. Overall Survival times in days (with any-cause death constituting an event)in all.
3. The proportion of patients with virological positivity, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days.
4. The proportion of patients with clinical improvement at day 14 after randomization.
5.Translational, including biomarker-related, research in banked bio-specimens 
1.Day 28
2.Day 28
3.Day 10
4.Day 14
5.Day 5,Day 10,discharge 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 2 
Date of First Enrollment (India)   22/07/2020 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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 in cancer 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 time to clinical improvement in COVID 19 cancer patients with pneumonia, and reduce 28-day mortality in  COVID-19 patients with pneumonia in cancer patients. The study will be carried out in 200 SARS-CoV positive cancer 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 primary endpoint will be calculated by Kaplan–Meier plots and compared between Arm 1 and Arm 3 & between Arm 2 and Arm 3 using the log-rank test. Hazard ratios with 95% confidence intervals will be calculated by the Cox proportional-hazards model.

 
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