| CTRI Number |
CTRI/2020/08/027403 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
25/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A retrospective assessment of risk factors for COVID- 19 in health care workers |
|
Scientific Title of Study
|
Assessment of risk factors for corona virus disease 2019 (COVID-19) in health care workes: a retrospective case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSukhyanti Kerai |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care
B.L. Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
1100002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSukhyanti Kerai |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care
B.L. Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
1100002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSukhyanti Kerai |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care
B.L. Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
1100002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
JLN Marg New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Sukhyanti Kerai |
Lok Nayak Hospital |
JL Nehru Marg
New Delhi
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health care workers involved in care of COVID-19 patients |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A case is defined as a health worker exposed in a health care setting to a COVID-19 patient in the 14 days prior to the health worker’s positive RT-PCR test for COVID-19 irrespective of clinical signs and symptoms.
A control is defined as a health worker exposed in a health care setting to a COVID-19 patient in the 14 days prior to recruitment; and who is not serologically tested positive. |
|
| ExclusionCriteria |
| Details |
A case would be excluded if he/she is having a confirmed COVID-19 case among their close contacts, including in their household, within the previous 14 days (with the exception of the COVID-19 patient(s) to which they were exposed) or when he/she is not involved in direct patient care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| factors responsible for COVID-19 infection in health care workers |
20 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical presentation of COVID 19 infection in health care workers and
adhrence of IPC measures by health care workers |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
07/09/2020 |
| 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="0"
Months="1"
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)?
|
|
Brief Summary
|
Healthcare workers are the frontline of the current COVID-19 pandemic response and as such are exposed to hazards that put them at the risk of acquiring infection. Understanding of COVID-19 infection in healthcare workers is crucial for maintaining sustainable workforce against the pandemic and to prevent the risk of transmission of infection to patients, colleagues and family. A retrospective case control study will be conducted to assess the risk factors for transmission of SARS CoV 2 infection in healthcare workers exposed to confirmed COVID-19 patients. Health care workers with positive RT-PCR test for COVID-19 irrespective of clinical signs or symptoms will be recruited as cases . The health care workers in the same health care facility involved in care of COVID-19 patients who are not serologically positive and are not classified as suspected or probable COVID-19 cases will be recruited as controls.Once a health care worker is identified as a case, the study team will approach him telephonically and invite them to participate in study.For identification of controls, health care workers exposed to COVID-19 patient during the same time period as" the case" will be chosen from the duty roster of that particular period. The controls will be enrolled in 1:3 period. For assessment of risk factors, information including demographic profile, co-morbid conditions, place of posting, average daily working hours, average patient load, hydroxycholoquine prophylaxis,compliance to infection control and preventive measures will be collected. |