| CTRI Number |
CTRI/2020/12/029761 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
what happens when a patient having connective tissue disease develops covid 19 infection. |
|
Scientific Title of Study
|
Covid-19 outcome in patients with Connective Tissue Disease with or without Interstitial Lung Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratima Singh |
| Designation |
Associate Professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT. OF RESPIRATORY MEDICINE, KIMS, CAMPUS-5, KIIT UNIVERSITY, PATIA, BHUBANESWAR.
KIMS STAFF QRS, KIIT UNIVERSITY
Khordha
ORISSA
751024
India |
| Phone |
8895613285 |
| Fax |
|
| Email |
drppratima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratima Singh |
| Designation |
Associate Professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT. OF RESPIRATORY MEDICINE, KIMS, CAMPUS-5, KIIT UNIVERSITY, PATIA, BHUBANESWAR.
KIMS STAFF QRS, KIIT UNIVERSITY
ORISSA
751024
India |
| Phone |
8895613285 |
| Fax |
|
| Email |
drppratima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratima Singh |
| Designation |
Associate Professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPT. OF RESPIRATORY MEDICINE, KIMS, CAMPUS-5, KIIT UNIVERSITY, PATIA, BHUBANESWAR.
KIMS STAFF QRS, KIIT UNIVERSITY
ORISSA
751024
India |
| Phone |
8895613285 |
| Fax |
|
| Email |
drppratima@gmail.com |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5,KIIT UNIVERSITY, PATIA, BBSR. |
|
|
Primary Sponsor
|
| Name |
PRATIMA SINGH |
| Address |
DEPT.OF RESPIRATORY MEDICINE, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS-5,KIIT UNIVERSITY, PATIA, BBSR. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PRATIMA SINGH |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
DEPT. OF CLINICAL IMMUNOLOGY & RHEUMATOLOGY.
DEPT.OF RESPIRATORY MEDICINE CAMPUS-5, KIIT UNIVERSITY, PATIA, BHUBANESWAR.
Khordha
ORISSA |
8895613285
drppratima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES. |
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 |
-All cases of Connective Tissue Disease with interstitial lung disease associated with Covid19 infection
-All cases of Connective Tissue Disease without interstitial lung disease associated with Covid19 infection |
|
| ExclusionCriteria |
| Details |
1. Co-morbidity like Chronic Kidney Disease,Chronic Liver Disesase.
2. Patient who does not give consent for study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CT THORAX SEVERITY SCORE |
0 AND 12WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6MinuteWalkDistance,ErythrocyteSedimentationRate |
0,12WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/12/2020 |
| 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="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
|
COVID AFFECTS CELLS WITH ACE2 RECEPTOR. THERE IS REDUCED ANGIOTENSIN 2 MRNA AND ITS ACTIVITY IN LUNG TISSUE OF IDIOPATHIC PULMONARY FIBROSIS AND BLEOMYCIN INDUCED LUNG FIBROSIS.WE ASSUME REDUCED COVID INFECTION DUE TO THIS. CTD MAY CAUSE INTERSTITIAL FIBROSIS AND SO DOES COVID, SO THERE MAY BE MORE LUNG DAMAGE. TREATMENT OF CONNECTIVE TISSUE DISEASE INVOLVES ANTI-INFLAMMATORY DRUGS WHICH MAY BE PROTECTIVE FOR COVID 19 INFECTION. SO THE OUTCOME NEEDS TO BE EVALUATED AND STUDIED. |