COVID-19NCT04339608
Max COVID19- Study
An observational study of COVID-19, run by Max Healthcare Insititute Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 10,000 participants
- Where
- 1 siteIndia
- Study dates
- 2 Apr 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Indian males and females currently living in India, OR
- All the employees of Max Super Speciality Hospital, New Delhi, India
Who cannot join
- Anyone who has filled the questionnaire once per household
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super Speciality Hospital, A Unit of Devki Devi Foundation
New Delhi, National Capital Territory of Delhi, 110017
Samreen Siddiqui, PhD, +919582865898, samreensiddiqui@maxhealthcare.com
Sujeet Jha, MRCP (U.K)
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 positive case
An individual identified with the clinical symptoms when tested positive for COVID-19
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start2 Apr 2020
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujeet Jha, MRCP (U.K), Principal investigator, Max Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339608
- Sponsor's protocol ID
- Covid-19/MHC/2020
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
Publications
Jha S, Soni A, Siddiqui S, Batra N, Goel N, Dey S, Budhiraja S, Naithani R. Prevalence of Flu-like Symptoms and COVID-19 in Healthcare Workers from India. J Assoc Physicians India. 2020 Jul;68(7):27-29.
PubMed 32602677
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04339608
- Acronym / sponsor ID
- Covid-19/MHC/2020
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Indian males and females currently living in India, OR
- All the employees of Max Super Speciality Hospital, New Delhi, India
Key exclusion criteria (1 listed)
- Anyone who has filled the questionnaire once per household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 positive case
Time frame: 4-8 weeks
An individual identified with the clinical symptoms when tested positive for COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 32602677Jha S, Soni A, Siddiqui S, Batra N, Goel N, Dey S, Budhiraja S, Naithani R. Prevalence of Flu-like Symptoms and COVID-19 in Healthcare Workers from India. J Assoc Physicians India. 2020 Jul;68(7):27-29.
- Individual participant dataSharing planned: Undecided. IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujeet Jha, MRCP (U.K) principal investigator
Max Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Max Healthcare Insititute Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujeet Jha, MRCP (U.K) (+919910609000, sujeet.jha@maxhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 positive case (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.