| 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
|
|
|
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
|
|
|
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. |