CTRI Number	CTRI/2020/06/026256 [Registered on: 30/06/2020] Trial Registered Prospectively
Last Modified On:	30/06/2020
Post Graduate Thesis	No
Type of Trial	Observational
Type of Study	Case Control Study
Study Design	Other
Public Title of Study Modification(s)	Resveratrol and copper for the treatment of COVID-19 pnuemonia.
Scientific Title of Study	Routine use of over-the-counter Nutraceuticals, Resveretrol-Copper with standard treatment in Hospitalized Patients With Pneumonia/ Acute Respiratory Distress Syndrome Due To SARS-CoV-2 (Covid-19)- Retrospective Analysis
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Rosemarie Desouza  Address  Department of Medicine, College building,First Floor, T.N.M.C and B.Y.L.Nair Hospital, Dr.A.L.Nair Road, Mumbai Mumbai MAHARASHTRA 400008 India  Phone  9820056230   Fax     Email  drrosemariedesouza@gmail.com
Details Contact Person Scientific Query	Name  Rosemarie Desouza  Address  Department of Medicine, College building,First Floor, T.N.M.C and B.Y.L.Nair Hospital, Dr.A.L.Nair Road, Mumbai MAHARASHTRA 400008 India  Phone  9820056230   Fax     Email  drrosemariedesouza@gmail.com
Details Contact Person Public Query	Name  Rosemarie Desouza  Address  Department of Medicine, College building,First Floor, T.N.M.C and B.Y.L.Nair Hospital, Dr.A.L.Nair Road, Mumbai MAHARASHTRA 400008 India  Phone  9820056230   Fax     Email  drrosemariedesouza@gmail.com
Source of Monetary or Material Support	Nil
Primary Sponsor	Name  TopiwalaNational Medical College and BYL Nair charitable Hospital  Address  Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra 400008  Type of Sponsor  Government medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Rosemarie Desouza  T.N.M.C and B.Y.L.Nair Hospital  First Floor, Department of Medicine, Dr.A.L.Nair Road, Mumbai-400008 Mumbai   9820056230 drrosemariedesouza@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Topiwala National College and B.Y.L. Nair CH. Hospital  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent	Type  Name  Details
Inclusion Criteria	Age From  18.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  Male and non-pregnant female patients 1.Have positive reverse-transcriptase–polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen 2.Have pneumonia confirmed by chest imaging 3.oxygen saturation (Sao2) of 94% or less while they were breathing ambient air 4.have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) abnormalities in any of these parameters
ExclusionCriteria	Details  Asymptomatic or only mildly symptomatic
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome Modification(s)	Outcome  TimePoints  To retrospectively access the clinical outcomes in the patients receiving R- Cu along with standard treatment versus those who received standard treatment.  10 Days
Secondary Outcome	Outcome  TimePoints  NIL  NIL
Target Sample Size	Total Sample Size="230" Sample Size from India="230"
Phase of Trial	N/A
Date of First Enrollment (India)	10/07/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="1" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details Modification(s)	NIL
Brief Summary	The COVID-19 pandemic has taken centre stage in the global search for drugs and vaccines for its prevention or cure. The purpose of this study is to access the clinical outcomes in patients receiving over-the-counter nutraceuticals - Resveratrol and Copper (R-Cu) for the treatment of severe COVID-19 infection. Resveratrol is a well-researched anti-oxidant plant polyphenol. A research group at Tata Memorial Centre, Mumbai, has shown that the combination of Resveratrol and Copper may be effective in the treatment of severe sepsis and Acute Respiratory Distress Syndrome (ARDS). Since sepsis and ARDS are the end stage complication of COVID-19 leading to death, it was hypothesised that R-Cu could be effective in preventing death due to severe COVID-19 infection.  A total of 30 SARS-CoV-2 (COVID-19) hospitalized patients with pneumonia / ARDS were administered R-Cu in addition to standard care during the period 23-04-2020 to 30-05-2020 at Topiwala National Medical College and B.Y.L Nair Hospital, Mumbai. Both nutraceuticals were used at doses several fold less than their daily permissible limit, obviating any safety concerns related to their use.  A retrospective, case-control study is being planned to compare the outcomes of these 30 patients against 200 matched controls who did not receive R-Cu. By doing this study, we will be  able to demonstrate the utility of R-Cu in patients with pneumonia / ARDS due to COVID-19 in addition to generating hypothesis for a future randomized controlled trial of this intervention in severe COVID-19 infection.