| CTRI Number |
CTRI/2020/12/029783 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
nintedanib therapy will improve management in covid 19 fibrosis if given early or not. |
|
Scientific Title of Study
|
Therapy with nintedanib –Does it improve outcome in patients of Covid-19 pneumonia if given early?
|
| 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.
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.
Khordha
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.
Khordha
ORISSA
751024
India |
| Phone |
8895613285 |
| Fax |
|
| Email |
drppratima@gmail.com |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR. |
|
|
Primary Sponsor
|
| Name |
PRATIMA SINGH |
| Address |
DEPT.OF RESPIRATORY MEDICINE,KIMS,CAMPUS-5, 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, 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 |
| Comparator Agent |
NA |
NA |
| Intervention |
NINTEDANIB 150 MG CAPSULE |
NINTEDANIB 150 MG CAPSULE TO BE GIVEN BD FOR 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 detected as COVID positive within ≤ 30 days or with history and CT suggestive of covid 19 .
CT-severity score ≥15 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 thorax findings(CT severity score). |
6WEEKS 12WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in CT-severity score |
6 WEEKS, 12 WEEKS |
|
|
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)
|
14/12/2020 |
| 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
|
NINTEDANIB HAS PROVEN ANTIFIBROTIC EFFECTS AND ITS USE IN IDIOPATHIC PULMONARY FIBROSIS IS WELL KNOWN. COVID 19 ALSO CAUSES LUNG FIBROSIS AND OXYGEN DEPENDENCY. EARLY INTERVENTION WITH ANTIFIBROTICS HAS BENEFITS BUT NOTHING IS CONCLUSIVELY PROVEN TILL DATE. SO THE NEED TO EVALUATE EARLY THERAPY WITH NINTEDANIB IN COVID 19 FIBROSIS. |