Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

Covid19 Clinical Trial

— EUROCOV  

Official title:

Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04682093
• Other study ID #: 123456
• Status: Enrolling by invitation
• Start date: March 9, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: December 2020
• Source: European Society for Emergency Medicine (EUSEM) Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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. In 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. Most 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). Anticipating the needs for hospitalization in ward and/or intensive care is crucial. Emergency departments are at the front line for triaging patients with suspected Covid-19 and referring them to the appropriate level of care. In Europe, the number of ED patients with suspected Covid-19 is variable; rate of hospitalization from ED reaches 40% for this population. Risk stratification and management decisions of patients presenting to the ED with suspected COVID-19 is a challenge for emergency physicians.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8000
• Est. completion date: February 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Adult patients (>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria
• Fever >= 38 °C
• respiratory symptoms (dyspnea, cough, expectorations)
• any other symptoms suggestive of COVID-19 including digestive signs (diarrhea, anosmia…)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Croatia	EUSEM RN Country lead	Zagreb
Finland	EUSEM RN Country lead	Hämeenlinna
France	EUSEM RN Country lead	Tours
Greece	EUSEM RN Country lead	Athens
Italy	EUSEM RN Country lead	Forlì

Sponsors (1)

Lead Sponsor	Collaborator
European Society for Emergency Medicine (EUSEM) Research Network

Countries where clinical trial is conducted

Croatia,  Finland,  France,  Greece,  Italy, 

References & Publications (4)

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. — View 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. — View 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. Erratum in: JAMA. 2020 Apr 21;323(15):1510. — View 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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospitalization	hospitalization after ED visit	30 days
Primary	length of hospital stay	Hospital LOS	30 days
Primary	in-hospital mortality	Death during hospitalization	30 days
Primary	ICU admission	ICU admission after ED visit	30 days