| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
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. |