CTRI Number |
CTRI/2020/07/026515 [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 Vs Standard Treatment In Mild Covid-19 infection with Cancer Patients. |
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 Cancer patients with SARS-CoV-2 Infection who are Asymptomatic Or Mildly Symptomatic 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 Shodhika,ACTREC-TMC,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 |
Scientific Officer F |
Affiliation |
ACTREC, Tata Memorial Centre |
Address |
Room No. 102,Khanolkar Shodhika,ACTREC-TMC,Sector No.22,Kharghar,Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
Phone |
7715019117 |
Fax |
|
Email |
vikramgota@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Tata Memorial Centre |
Address |
Dr Ernest Borges Rd, Parel East, Mumbai, Maharashtra 400012
|
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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 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
|
|
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 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. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1.Male and non-pregnant female cancer patients 18 years of age or older.
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 will be eligible
7. Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate level. |
|
ExclusionCriteria |
Details |
1.Cancer diagnosis not proven
2. Have pneumonia confirmed by chest imaging, 3. Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air
4.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 |
the proportion of patients who suffer clinical deterioration OR viral persistence at Day 10 from the date of randomization (excluding the date of randomization). |
10 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.All-cause mortality at 28 days after randomization (28-day mortality)
2.Overall Survival times in days (with any-cause death constituting an event)
3.The proportion of patients with virological positivity.
4. Translational, including biomarker-related, research in banked bio-specimens. |
1.Day 28
2.Day 28
3.Day 10
4.Day 0,5,10,Discharge |
|
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)
|
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 with cancer 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 cancer patients. This study will be carried out in 300 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 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. |