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Max COVID19- Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339608
Recruitment Status : Unknown
Verified April 2020 by Max Healthcare Insititute Limited.
Recruitment status was:  Recruiting
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Max Healthcare Insititute Limited

Brief 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.

Condition or disease
COVID-19

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. COVID-19 positive case [ Time Frame: 4-8 weeks ]
    An individual identified with the clinical symptoms when tested positive for COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will include all the healthcare workers of Max Super Speciality Hospital, New Delhi, India, and all males and females from the general population. One questionnaire will be filled up per household.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339608


Contacts
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Contact: Sujeet Jha, MRCP (U.K) +919910609000 sujeet.jha@maxhealthcare.com

Locations
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India
Max Super Speciality Hospital, A Unit of Devki Devi Foundation Recruiting
New Delhi, Delhi, India, 110017
Contact: Samreen Siddiqui, PhD    +919582865898    samreensiddiqui@maxhealthcare.com   
Principal Investigator: Sujeet Jha, MRCP (U.K)         
Sub-Investigator: Sandeep Budhiraja, MRCP (U.K), MD         
Sponsors and Collaborators
Max Healthcare Insititute Limited
Investigators
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Principal Investigator: Sujeet Jha, MRCP (U.K) Max Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Max Healthcare Insititute Limited
ClinicalTrials.gov Identifier: NCT04339608    
Other Study ID Numbers: Covid-19/MHC/2020
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases