| CTRI Number |
CTRI/2021/12/038759 [Registered on: 20/12/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical and Demographic Profile of Severe COVID 19 Pneumonia and factors associated with poor outcome |
|
Scientific Title of Study
|
Clinical, Laboratory Profile and in hospital outcome in severe COVID 19 Infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Darshan J Kanani |
| Designation |
Resident Doctor |
| Affiliation |
SMT NHL Municipal Medical college and SVPIMSR , Ahmedabad |
| Address |
Dept of General Medicine , 1st floor , SVPIMSR ,Nr Ellisbridge, Paldi, Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
7600123403 |
| Fax |
|
| Email |
darshan7600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshan J Kanani |
| Designation |
Resident doctor |
| Affiliation |
Smt NHL Municipal Medical college |
| Address |
Department of General Medicine, First floor, SVP Hospital, near Ellisbridge, Paldi, Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
7600123403 |
| Fax |
|
| Email |
darshan7600@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhara Roy |
| Designation |
Associate Professor |
| Affiliation |
Smt NHl Municipal Medical college |
| Address |
Department of General Medicine, First floor, SVP Hospital, near Ellisbridge, Paldi, Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
|
| Fax |
|
| Email |
dharabhavesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Vallabhbhai Patel Institute of Medical Sciences and Research (SVPIMSR), Near ellisbridge , Paldi, Ahmedabad -380006 |
|
|
Primary Sponsor
|
| Name |
Smt NHL Municipal Medical College |
| Address |
Smt NHL Municipal Medical College, ellisbridge , ahmedabad |
| Type of Sponsor |
Other [Municipal Medical College] |
|
|
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 Darshan J Kanani |
Sardar Vallabhbhai Patel Institute of Medical Sciences (SVPIMSR) |
Department of General Medicine, First floor, SVP Hospital, near Ellisbridge, Paldi, Ahmedabad
Ahmadabad
GUJARAT |
7600123403
darshan7600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
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, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of >18 years of age admitted with COVID 19 Pneumonia (RAT / RT-PCR confirmed) at tertiary care center fulfilling criteria of severe covid 19 infection
|
|
| ExclusionCriteria |
| Details |
AGE < 18 Years
Patient with Mild and Moderate Covid 19 infection
Patients who take Leave Against Medical Advice
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DEMOGRAPHIC AND CLINICAL PROFILE OF PATIENTS ADMITTED WITH SEVERE COVID 19 INFECTION |
At Baseline and periodic Monitoring till Discharge/Death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find in Hospital outcome and to identify predictors of Morbidity and Mortality |
At Baseline and periodic Monitoring till Discharge/Death |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/12/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design and Duration: It is an Observational Prospective study (Duration -1 year from IRB and CTRI approval) carried out in hospitalized patients in tertiary care centre involving severe COVID 19 Pneumonia
Hypothesis: - In Patients with Covid 19 Pneumonia who present late to the hospital from symptom onset, having comorbidities like DM 2 & HTN , older age, have raised inflammatory markers have higher chances of developing severe Covid 19 pneumonia requiring oxygen support or ventilatory support ,have prolonged hospital stay and have poor in hospital outcome.
- Hence, Are Comorbidities (DM2 , Hypertension) , Age , Late presentation to hospital, Raised Inflammatory markers directly related to severity of the disease?
- So, We would like to study patients with severe COVID 19 Pneumonia to answer above question.
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