| CTRI Number |
CTRI/2020/08/027042 [Registered on: 09/08/2020] Trial Registered Prospectively |
| Last Modified On: |
01/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Secondary attack rate of COVID 19, Kerala |
|
Scientific Title of Study
|
Secondary attack rate of COVID 19: Analysis of contacts of COVID 19 cases admitted in a Tertiary care center, Northern district of Kerala, India, A Cross- sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha S S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kannur |
| Address |
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala
Kannur
KERALA
670005
India |
| Phone |
9947107949 |
| Fax |
|
| Email |
dranithaprasanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anitha S S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kannur |
| Address |
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala
Kannur
KERALA
670005
India |
| Phone |
9947107949 |
| Fax |
|
| Email |
dranithaprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anitha S S |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kannur |
| Address |
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala
Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala
Kannur
KERALA
670005
India |
| Phone |
9947107949 |
| Fax |
|
| Email |
dranithaprasanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala |
|
|
Primary Sponsor
|
| Name |
Anitha S S |
| Address |
Community Medicine Department
Academic block fifth floor
Government Medical College Kannur Kerala |
| Type of Sponsor |
Other [Anitha S S] |
|
|
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 |
| Anitha S S |
Government Medical College Kannur Kerala |
Community Medicine Department
Academic block fifth floor
Government Medical College Kannur Kerala
Kannur
KERALA |
9947107949
dranithaprasanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary contacts of COVID 19 cases admitted in tertiary care center will be screened for onset of COVID 19 within one incubation period (14days) from last exposure to COVID 19 case |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary contacts of COVID 19 cases admitted in tertiary care center |
|
| ExclusionCriteria |
| Details |
In situations where contact tracing cannot be completed, such COVID 19 cases will not be included for calculating Secondary attack rate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Secondary attack rate of COVID 19 |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic variables affecting onset of COVID 19 among primary contacts of COVID 19 cases |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="255" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| Date of Study Completion (India) |
11/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
3. Anitha S Saraswathy, Rameela Sanya, Jayasree A. Kumaran. Secondary attack rate of COVID-19: Analysis of contacts of COVId-19 cases admitted in a tertiary care centre, Northern District of Kerala, India. International Journal of Community Medicine and Public Health. Saraswathy AS et al. Int J Community Med Public Health. 2020 Dec;7(12):5111-5114 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a hospital record based retrospective study to calculate the secondary attack rate of COVID 19. Primary contacts of COVID 19 cases admitted in a tertiary care center in North Kerala will be assessed for disease onset within one incubation period (14 days) from the date of last exposure to the case.Primary contacts of 14 index cases admitted in the tertiary
care hospital during study period were included in the
study to assess onset of COVID-19 among them. Secondary attack rate was found to be 5.88%, secondary clinical attack rate 2.35% and secondary infection
rate 3.53%. Among those contacts that developed disease, 80% were household contacts. |