Clinical trial NCT04682093: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED
Official title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Covid19
Emergencies
epidemiology
prognosis
Lead sponsor: European Society for Emergency Medicine (EUSEM) Research Network
Sponsor class: NETWORK
First posted: 2020-12-23
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adult patients (\>= 18 years old) attending the ED with a clinical suspicion of COVID-19 based on the presence of the following criteria

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: hospitalization
timeFrame: 30 days
measure: length of hospital stay
timeFrame: 30 days
measure: in-hospital mortality
timeFrame: 30 days
measure: ICU admission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: EUSEM RN Country lead
city: Hämeenlinna
country: Finland
facility: EUSEM RN Country lead
city: Tours
country: France
facility: EUSEM RN Country lead
city: Athens
country: Greece
facility: EUSEM RN Country lead
city: Forlì
country: Italy
facility: EUSEM RN Country lead
Study officials:
affiliation: EUSEM Research network chair
name: Said LARIBI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.