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CTRI Number  CTRI/2020/07/026510 [Registered on: 12/07/2020] Trial Registered Prospectively
Last Modified On: 10/07/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Descriptive study 
Study Design  Other 
Public Title of Study   Clinical presentation, Management, Treatment and Outcome of COVID patients 
Scientific Title of Study   Clinical presentation, Treatment and Outcomes of COVID patients admitted at a Multi-specialty hospital in Chennai - COVID Registry. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Melvin George 
Designation  Consultant - Clinical Research 
Affiliation  Hindu Mission Hospital 
Address  Room No:101 Clinical Research Department, Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.

Kancheepuram
TAMIL NADU
600045
India 
Phone  9894133697  
Fax    
Email  melvingeorge2003@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Melvin George 
Designation  Consultant- Clinical Research 
Affiliation  Hindu Mission Hospital 
Address  Room No:101 Clinic Research Department, Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.

Kancheepuram
TAMIL NADU
600045
India 
Phone  9894133697  
Fax    
Email  melvingeorge2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr D K Sriram 
Designation  Consultant Diabetologist 
Affiliation  Hindu Mission Hospital 
Address  Room No:54 Diabetology Clinic, Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.

Kancheepuram
TAMIL NADU
600045
India 
Phone  9003281111  
Fax    
Email  drdeekay@hindumissionhospital.org  
 
Source of Monetary or Material Support  
Hindu Mission Hospital No:103 GST Road, West Tambaram, Chennai-45 
 
Primary Sponsor  
Name  Hindu Mission Hospital 
Address  103 GST Road West Tambaram Chennai 600045 
Type of Sponsor  Private hospital/clinic 
 
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 Melvin George  Hindu Mission Hospital, 103 GST Road West Tambaram  Room No: 101 Clinical Research Department, Hindu Mission Hospital, 103 GST road, West Tambaram. Chennai-600045.
Kancheepuram
TAMIL NADU 
9894133697

melvingeorge2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hindu Mission Hospital Institutional Ethics Committee  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 
 
Inclusion Criteria  
Age From  0.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All hospitalized patients with COVID-19.
Patients of any age groups (Child, Adult, and older adult) of either gender including minors and pregnant womens.
Patients receiving any specific treatment for COVID-19 disease
 
 
ExclusionCriteria 
Details  Suspected patients with COVID-19, not confirmed by the laboratory.
Patients who refused to receive medical treatments.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical Improvement  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
RT-PCR negativity.
Reduction in inflammatory markers.
Rate of improvement in radiological findings
 
2 weeks 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   17/07/2020 
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="1"
Months="0"
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  

COVID-19 is an infectious disease caused by a newly discovered coronavirus which affects different people in different ways. Globally, this virus will continue to have a major impact on humans health. As the infected people will develop mild to moderate illness and recover without hospitalization, which includes symptoms such as fever, dry cough, and tiredness. However, older people and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. Some of the serious symptoms include difficulty breathing or shortness of breath, chest pain or pressure, loss of speech or movement, eventually resulting in death (in some cases). Though only four months have elapsed since the emergence of COVID-19 only a few treatments have received global wide attention. Physicians worldwide have administered numerous treatments off-label to treat COVID  but identifying the full range of treatment is decisive for the treating physicians. So due to the lack of a precise treatment plan, this registry study data will help to understand the nature of disease more and provide an effective treatment plan for COVID-19 in the long term.

 
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