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NCT04339608 Clinical Trial

Max COVID19- Study

COVID-19 Clinical Trial

Official title:
A Prospective, Longitudinal, Observational Study of Healthcare Workers and the General Population to Watch for Flu-like Symptoms in Suspicion of COVID 19

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04339608
Other study ID # Covid-19/MHC/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2, 2020
Est. completion date June 30, 2020

Study information
Verified date April 2020
Source Max Healthcare Insititute Limited
Contact Sujeet Jha, MRCP (U.K)
Phone +919910609000
Email sujeet.jha@maxhealthcare.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In view of the increasing cases of COVID-19 in India and the possibility of the exponential rise of the cases, this study has been designed to collect data of the healthcare workers of Max Hospital and the general population. Our objective is to identify individuals with flu-like symptoms in suspicion of COVID-19 and follow them weekly up to 8 weeks until the pandemic resolves. The data will be collected through an online questionnaire circulated via Emails or WhatsApp.

Description:

The primary objective of this study is to screen and identify individuals with flu-like symptoms and follow-them up weekly. In the study, baseline data will be collected online and then weekly follow up will be done with the participants for 4 weeks via opted communication method. There will be no physical contact and we are also avoiding the use of papers so as to avoid possible transmission. Participation in this study will be entirely voluntary and the questionnaire will be accessible to the participants only when they mark "Agree" on the form.

The data collection form is available in English and Hindi.

The study questionnaire includes questions related to general health status, clinical symptoms, Food security, and job security.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date June 30, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Indian males and females currently living in India, OR

- All the employees of Max Super Speciality Hospital, New Delhi, India

Exclusion Criteria:

- Anyone who has filled the questionnaire once per household

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Max Super Speciality Hospital, A Unit of Devki Devi Foundation New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 positive case An individual identified with the clinical symptoms when tested positive for COVID-19 4-8 weeks
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