NCT04682093

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
5 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

December 22, 2020

Last Update Submit

December 23, 2020

Conditions

Covid19

Keywords

Covid19Emergenciesepidemiologyprognosis

Outcome Measures

Primary Outcomes (4)

  • hospitalization

    hospitalization after ED visit

    30 days

  • length of hospital stay

    Hospital LOS

    30 days

  • in-hospital mortality

    Death during hospitalization

    30 days

  • ICU admission

    ICU admission after ED visit

    30 days

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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…)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

EUSEM RN Country lead

Zagreb, Croatia

Location

EUSEM RN Country lead

Hämeenlinna, Finland

Location

EUSEM RN Country lead

Tours, France

Location

EUSEM RN Country lead

Athens, Greece

Location

EUSEM RN Country lead

Forlì, Italy

Location

Related Publications (4)

  • 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: 32091533BACKGROUND

  • 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: 32171076BACKGROUND

  • 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: 32167524BACKGROUND

  • 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.

    PMID: 32125362BACKGROUND

MeSH Terms

Conditions

COVID-19Emergencies

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Said LARIBI, MD, PhD

    EUSEM Research network chair

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 23, 2020

Study Start

March 9, 2020

Primary Completion

January 31, 2021

Study Completion

February 28, 2021

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

FR(1)FI(1)CR(1)GR(1)IT(1)