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CTRI Number  CTRI/2020/07/026340 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 02/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Micronutrient]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the role of Zinc combined with standard treatment for COVID-19 
Scientific Title of Study   Prospective study to assess therapeutic role of Zinc in COVID-19 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramen Goel 
Designation  Director, Center for Metabolic Surgery 
Affiliation  Wockhardt Hospitals 
Address  C-10, 14th floor, Center for metabolic Surgery Wockhardt Hospitals, Agripada

Mumbai
MAHARASHTRA
400011
India 
Phone  9820170763  
Fax    
Email  ramengoel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramen Goel 
Designation  Director, Center for Metabolic Surgery 
Affiliation  Wockhardt Hospitals 
Address  C-10, 14th floor, Center for Metabolic Surgery Wockhardt Hospitals, Agripada

Mumbai
MAHARASHTRA
400011
India 
Phone  9820170763  
Fax    
Email  ramengoel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramen Goel 
Designation  Director, Center for Metabolic Surgery 
Affiliation  Wockhardt Hospitals 
Address  C-10, 14th floor, Center For Metabolic Surgery Wockhardt Hospitals, Agripada

Mumbai
MAHARASHTRA
400011
India 
Phone  9820170763  
Fax    
Email  ramengoel@gmail.com  
 
Source of Monetary or Material Support  
Wockhardt Hospitals Agripada, Mumbai 
 
Primary Sponsor  
Name  Ramen Goel 
Address  C-10, 14th floor, Wockhardt Hospital, Agripada, Mumbai-400011 
Type of Sponsor  Other [Self funded] 
 
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 
Dr Ramen Goel  Wockhardt Hospitals  COVID ward and ICU Wockhardt Hospitals Agripada
Mumbai
MAHARASHTRA 
9820170763

ramengoel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Wockhardt Hospitals 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard treatment  Standard medications 
Intervention  Zinc sulphate 100mg  Micronutrient Zinc combined with standard treatment Tab Zinc Sulphate 100 mg OD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed with COVID-19 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women
2. End stage CKD (chronic kidney disease)
3. Patients with dementia, learning disability, mental health needs
4. Unable to understand the procedures and protocol
5. Deemed unfit for the study according to the investigator
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms
Duration of stay, ICU admission, ventilator requirement, complications, discharge 
Baseline, day 1, day 5, day 7, day 14 or till discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Symptom resolution  14 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   11/07/2020 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Brief Summary   The COVID-19 pandemic has taken a major burden on healthcare. Several treatment modalities have been tried for treatment of the disease and reducing mortality. Micronutrient zinc is known to modulate antiviral and antibacterial immunity and regulate inflammatory response. Despite the lack of evidence, certain indications suggest that modulation of zinc status may be beneficial in COVID‑19. In vitro experiments demonstrate that Zinc possesses antiviral activity through inhibition of SARS‑CoV RNA polymerase. This effect may underlie therapeutic efficiency of chloroquine known to act as zinc ionophore. Zinc in therapeutic doses (50-100 mg/day) has no side effects and has been used for other viral illnesses in the past. Through our study, we seek to identify the role of zinc supplementation in addition to standard treatment to improve the outcomes of patients diagnosed with COVID-19. This will pave the way for future research and improve treatment modalities for the infection. 
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