Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:17 PM
Study NCT ID:
NCT04339608
Status:
UNKNOWN
Last Update Posted:
2020-04-09
First Post:
2020-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Max COVID19- Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COVID-19 positive case', 'timeFrame': '4-8 weeks', 'description': 'An individual identified with the clinical symptoms when tested positive for COVID-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32602677', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe data collection form is available in English and Hindi.\n\nThe study questionnaire includes questions related to general health status, clinical symptoms, Food security, and job security.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indian males and females currently living in India, OR\n* All the employees of Max Super Speciality Hospital, New Delhi, India\n\nExclusion Criteria:\n\n* Anyone who has filled the questionnaire once per household'}, 'identificationModule': {'nctId': 'NCT04339608', 'briefTitle': 'Max COVID19- Study', 'organization': {'class': 'OTHER', 'fullName': 'Max Healthcare Insititute Limited'}, 'officialTitle': 'A Prospective, Longitudinal, Observational Study of Healthcare Workers and the General Population to Watch for Flu-like Symptoms in Suspicion of COVID 19', 'orgStudyIdInfo': {'id': 'Covid-19/MHC/2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '110017', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Samreen Siddiqui, PhD', 'role': 'CONTACT', 'email': 'samreensiddiqui@maxhealthcare.com', 'phone': '+919582865898'}, {'name': 'Sujeet Jha, MRCP (U.K)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sandeep Budhiraja, MRCP (U.K), MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Max Super Speciality Hospital, A Unit of Devki Devi Foundation', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Sujeet Jha, MRCP (U.K)', 'role': 'CONTACT', 'email': 'sujeet.jha@maxhealthcare.com', 'phone': '+919910609000'}], 'overallOfficials': [{'name': 'Sujeet Jha, MRCP (U.K)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Max Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max Healthcare Insititute Limited', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}