| CTRI Number |
CTRI/2020/11/029437 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
26/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate post COVID-19 lung damage.
|
|
Scientific Title of Study
|
A retrospective study to evaluate clinical and radiological course in COVID 19 interstitial pneumonia.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| COVIP/2020/001 Version 01 Dated 19/Oct/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bornali Datta |
| Designation |
Director, Department of Respiratory and Sleep Medicine |
| Affiliation |
Medanta The Medicity Gurugram Haryana India |
| Address |
Department of Respiratory and Sleep Medicine, Medanta The Medicity, Sector 38 Gurgaon Haryana 122 001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9818462626 |
| Fax |
|
| Email |
bornalidatta@googlemail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bornali Datta |
| Designation |
Director, Department of Respiratory and Sleep Medicine |
| Affiliation |
Medanta The Medicity Gurugram Haryana India |
| Address |
Department of Respiratory and Sleep Medicine, Medanta The Medicity, Sector 38 Gurgaon Haryana 122 001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9818462626 |
| Fax |
|
| Email |
bornalidatta@googlemail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bornali Datta |
| Designation |
Director, Department of Respiratory and Sleep Medicine |
| Affiliation |
Medanta The Medicity Gurugram Haryana India |
| Address |
Department of Respiratory and Sleep Medicine, Medanta The Medicity, Sector 38 Gurgaon Haryana 122 001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9818462626 |
| Fax |
|
| Email |
bornalidatta@googlemail.com |
|
|
Source of Monetary or Material Support
|
| Medanta Institute of Education and Research, Medanta-The Medicity, Sector – 38, Gurgaon, Haryana 122 001, India
|
|
|
Primary Sponsor
|
| Name |
Medanta Institute of Education and Research |
| Address |
Medanta-The Medicity, Sector – 38, Gurgaon, Haryana 122 001, India |
| Type of Sponsor |
Research institution |
|
|
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 Bornali Datta |
Medanta-The Medicity |
Room No-03,Department of Respiratory and Sleep Medicine,
Devision-Respiratory and Sleep Medicine
Gurgaon
HARYANA |
9818462626
bornalidatta@googlemail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients confirmed with COVID-19, admitted to Medanta-The Medicity, Gurgaon, India.
2. Patients with moderate or severe COVID 19 pneumonia, admitted to ward or ICU. |
|
| ExclusionCriteria |
| Details |
1. Age <18 years
2. Patients with mild COVID 19
3. Pregnant female
4. Patients with history of COVID-19 Interstitial Pneumonia treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
High-resolution computed tomography (HRCT) features of COVID 19 at presentation and 12 weeks later
|
High-resolution computed tomography (HRCT) features of COVID 19 at presentation and 12 weeks later
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of therapy used
Role of anti-fibrotic medications
Pulmonary Function Test: Spirometry
Blood tests-complete blood count, coagulopathy studies, D-dimers, Ferritin, CRP, comprehensive metabolic panel to include electrolytes, liver and renal function tests |
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/12/2020 |
| 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="2"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a retrospective de-identified observational study to monitor the clinical and radiological course in patients with moderate or severe COVID-19 interstitial pneumonia and to study the changes in Computed Tomography findings after four weeks. Patients confirmed with COVID-19, admitted to Medanta-The Medicity and patients with moderate or severe COVID 19 pneumonia, admitted to ward or ICU will be included in the study. |