| CTRI Number |
CTRI/2020/12/029814 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
comparison of two drugs for better treatment of covid-19 related lung problems |
|
Scientific Title of Study
|
Nintedanib Vs Pirfenidone in management of Covid19 related lung abnormality |
| 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,KIIT UNIVERSITY, BBSR
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,KIIT UNIVERSITY, BBSR
KIMS STAFF QRS, KIIT UNIVERSITY
Khordha
ORISSA
751024
India |
| Phone |
8895613285 |
| Fax |
|
| Email |
drppratima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Sahoo |
| Designation |
DIRECTOR, CHAKRADHARA INSTITUTE OF REHABILITATION SCIENCES |
| Affiliation |
CHAKRADHARA INSTITUTE OF REHABILITATION SCIENCES |
| Address |
CIRS, BILIPADA, PS-PIPILI, DIST-PURI.
CIRS, PLOT NUMBER F-10, BJB NAGAR, BHUBANESWAR , 751014.
Khordha
ORISSA
752104
India |
| Phone |
9437014577 |
| Fax |
|
| Email |
deepakcirs@gmail.com |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
PRATIMA SINGH |
| Address |
DEPT. OF RESPIRATORY MEDICINE, KIMS, KIIT UNIVERSITY, BHUBANESWAR. |
| 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 RESPIRATORY MEDICINE, KIMS, 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 |
NINTEDANIB |
150 MG CAPSULE TO BE GIVEN BD FOR A DURATION OF 12 WEEKS MAXIMUM. |
| Comparator Agent |
tab pirfenidone 600 mg tid |
600 MG TAB TO BE GIVEN TID FOR A DURATION OF 12 WEEKS MAXIMUM. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All cases of covid 19 pneumonia who were diagnosed as COVID positive ≥15 days back or antibody positive and continue to be breathless symptomatically, have SPo2 ≤96%, CT-severity score ≥10 and CORADS-4/5/6 |
|
| ExclusionCriteria |
| Details |
-Patients having other interstitial lung diseases.
- Patient having CKD or creatinine clearance <30 and CLD with deranged LFT will be excluded.
-Not fulfilling the criteria for study
-Not giving consent for study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in CT-severity score
Improvement in Arterial Blood Gas.
|
0, 6weeks, 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in 6Minute Walk Distance. |
6 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
ON PROCESS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
NINTEDANIB AND PIRFENIDONE HAVE PROVEN ANTI FIBROTIC PROPERTIES AS SEEN IN THEIR ROLE IN TREATMENT OF IDIOPATHIC INTERSTITIAL FIBROSIS. COVID 19 ALSO LEADS TO LUNG FIBROSIS AND OXYGEN DEPENDENCY.THE MANAGEMENT OF COVID RELATED LUNG FIBROSIS SHOULD INCLUDE NINTEDANIB AS OUR STUDY RESULTS. |