Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT04682093
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004630', 'term': 'Emergencies'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospitalization', 'timeFrame': '30 days', 'description': 'hospitalization after ED visit'}, {'measure': 'length of hospital stay', 'timeFrame': '30 days', 'description': 'Hospital LOS'}, {'measure': 'in-hospital mortality', 'timeFrame': '30 days', 'description': 'Death during hospitalization'}, {'measure': 'ICU admission', 'timeFrame': '30 days', 'description': 'ICU admission after ED visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Emergencies', 'epidemiology', 'prognosis'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32091533', 'type': 'BACKGROUND', 'citation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.'}, {'pmid': '32171076', 'type': 'BACKGROUND', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}, {'pmid': '32167524', 'type': 'BACKGROUND', 'citation': 'Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.'}, {'pmid': '32125362', 'type': 'BACKGROUND', 'citation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204.'}]}, 'descriptionModule': {'briefSummary': 'This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.', 'detailedDescription': 'Over the past 6 months, the world has faced a novel infection disease outbreak, due to a novel coronavirus, the severe acute respiratory syndrome coronavirus (SARS-CoV2), with a massive impact on healthcare resource.\n\nIn Europe, numbers of confirmed cases continue to rise. Europe is currently one of the regions with the highest number of Covid-19 cases and deaths due to this emergent diseases.\n\nMost COVID-19 infected patients present with mild to moderate acute respiratory symptoms, including cough, fever, dyspnea and pneumonia. About 20% will present with severe or critical manifestations of the disease, including pneumonia, respiratory failure and acute respiratory distress syndrome (ARDS).\n\nAnticipating the needs for hospitalization in ward and/or intensive care is crucial.\n\nEmergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care.\n\nIn Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population.\n\nRisk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Adult patients (\\>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria\n* Fever \\>= 38 °C\n* respiratory symptoms (dyspnea, cough, expectorations)\n* any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia…)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04682093', 'acronym': 'EUROCOV', 'briefTitle': 'Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED', 'organization': {'class': 'NETWORK', 'fullName': 'European Society for Emergency Medicine (EUSEM) Research Network'}, 'officialTitle': 'Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)', 'orgStudyIdInfo': {'id': '123456'}}, 'contactsLocationsModule': {'locations': [{'city': 'Zagreb', 'country': 'Croatia', 'facility': 'EUSEM RN Country lead', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Hämeenlinna', 'country': 'Finland', 'facility': 'EUSEM RN Country lead', 'geoPoint': {'lat': 60.99596, 'lon': 24.46434}}, {'city': 'Tours', 'country': 'France', 'facility': 'EUSEM RN Country lead', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'EUSEM RN Country lead', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Forlì', 'country': 'Italy', 'facility': 'EUSEM RN Country lead', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}], 'overallOfficials': [{'name': 'Said LARIBI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EUSEM Research network chair'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society for Emergency Medicine (EUSEM) Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}