| CTRI Number |
CTRI/2021/10/037090 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study lung fuction and residual lung damage in COVID 19 patients who recover from the infections. |
|
Scientific Title of Study
|
Lung function impairment and injury in post COVID 19 infection |
| Trial Acronym |
LIMPCov |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devasahayam J Christopher |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine,
ISSCC building,
Ida Scudder Road, Christian Medical College,
Vellore
India
Vellore
TAMIL NADU
632004
India |
| Phone |
09443306573 |
| Fax |
0416-2211570 |
| Email |
djchris@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Devasahayam J Christopher |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine,
ISSCC building,
Ida Scudder Road, Christian Medical College,
Vellore
India
Vellore
TAMIL NADU
632004
India |
| Phone |
09443306573 |
| Fax |
0416-2211570 |
| Email |
djchris@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Devasahayam J Christopher |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine,
ISSCC building,
Ida Scudder Road, Christian Medical College,
Vellore
India
Vellore
TAMIL NADU
632004
India |
| Phone |
09443306573 |
| Fax |
0416-2211570 |
| Email |
djchris@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical college, Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Ethics Committee Silver, Office of Research, I Floor, Carman Block, Christian Medical College, Vellore, Tamil Nadu, 632002. |
| Type of Sponsor |
Other [non profit organization] |
|
|
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 DJ Christopher |
Christian Medical College |
Department of Pulmonary Medicine
Ida Scudder Road,
Vellore
TAMIL NADU |
09443306573
0416-2211570
djchris@cmcvellore.ac.in |
|
|
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: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult inpatients (more than 18 years and older) with positive SARS-CoV-2 RNA detection (throat swab) results and diagnosed with COVID-19
2. Willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to consent or unable to come for follow-up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Lung function paramenters: FEV1, FVC, TLC, RV, DLco, DLco/VA
2.6 Min walk test parameters: 6 min walk distance, Distance Saturation Product, Lowest SPO2, Dyspnea Borg scale
3.CXR/HRCT: Fibrosis, Consolidation, bronchiectasis etc.
4.SGRQ: Respirtory symptoms, problems, treatment & activities
|
4 to 6 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
18/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published after the completion of the study in indexed journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since the initial reports of the recent new COVID-19 virus infection (SARS-CoV2) in December 2019, the outbreak has rapidly spread and escalated resulting in this disease being formally declared a pandemic on 11 March 2020 by the World Health Organization. Transmission dynamics are currently evolving and high person-to-person spread has been confirmed in community and healthcare settings in China and other countries. Pneumonia appears to be the most frequent serious manifestation of infection and Acute respiratory distress syndrome (ARDS) is the major complication in patients, with high fatality rate. These are likely to heal with fibrosis and result in residual lung damage and lung function impairment. This has not been well studied. When the study was conceived, only one study in China has tested lung function in a small number of subjects, subsequently few others had published their findings. There are no studies from India. We propose to evaluate these patients with lung function testing, exercise capacity, lung scarring as seen by imaging and health related quality of life |