| CTRI Number |
CTRI/2021/06/034269 [Registered on: 16/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Presentation of Second Wave of Covid-19 Patients in Vaccinated People |
|
Scientific Title of Study
|
Clinical, Laboratory and Radiological Profile of Second Wave of Covid-19 Patients with Special Reference to Vaccination Status |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Beleswar, Nayabazar, Cuttack, 753004
Cuttack
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Beleswar, Nayabazar, Cuttack, 753004
Cuttack
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Beleswar, Nayabazar, Cuttack, 753004
Cuttack
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
drdebasis8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Science, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
KIMS HOSPITAL |
| Address |
BHUBANESWAR, ODISHA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Debasis Behera |
Kalinga Institute of Medical Science, Bhubaneswar |
Department of Pulmonary Medicine, Kalinga Institute of Medical Science, Bhubaneswar
OPD Room No.8
Khordha
ORISSA |
09971852101
drdebasis8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kalinga Institute of Medical Science, Bhubaneswar |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted with age > 18 years to COVID hospital, KIMS, Bhubaneswar.
Written informed consent available.
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Presence of end stage lung, renal, hepatic and cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the clinical, laboratory and radiological manifestation of COVID-19 patients affected in second wave.
2. To compare the clinical presentation, laboratory and radiological manifestations between vaccinated and unvaccinated groups.
|
1-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the severity of disease during presentation and its corelation with that of the vaccination. |
1-6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/06/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In India, there is a scanty data regarding the presentation of patients in second wave of covid-19 due to the mutant strain. More number of fully vaccinated people are also getting affected but the data regarding the same is also sparse. So knowing the clinical presentation of covid-19 with its variations in symptomatology will guide the clinicians in appropriate clinical management. A Special focus on the clinical scenario will help in better information to Policy planners. Our KIMS is being a tertiary care centre in covid-19 since march 2020 will be a information hub for all cases of COVID-19. |