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Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room (ReCovER)

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ClinicalTrials.gov Identifier: NCT04351854
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Volker Burst, University of Cologne

Brief Summary:
Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.

Condition or disease Intervention/treatment
Corona Virus Infection SARS-CoV 2 Other: Retrospective data collection

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Registry for Clinical Presentation and Management of Patients With COVID-19 in the Emergency Room
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with SARS-CoV-2-infection
Patients with clinical suspicion or evidence of SARS-CoV-2-infection on presentation in the ED
Other: Retrospective data collection
Retrospective data collection to identify predicting factors in the clinical picture of COVID-19 patients presenting to the ED.

Control group
Particularly, controls will be identified retrospectively at the same hospitals based on matching of demographics, underlying diseases and duration of hospital stay (i.e. one control per case, both in the same hospital). Moreover, the mere suspicion of SARS-CoV-2-infection on admission in the ED is sufficient for enrolment. A considerable portion of these patients are actually not infected and serve as internal control.
Other: Retrospective data collection
Retrospective data collection to identify predicting factors in the clinical picture of COVID-19 patients presenting to the ED.




Primary Outcome Measures :
  1. Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission. [ Time Frame: 6 months ]
    Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.


Secondary Outcome Measures :
  1. Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED [ Time Frame: 6 months ]
    Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED

  2. Identification of the ratio of patients with mild or moderate to severe disease [ Time Frame: 6 months ]
    Identification of the ratio of patients with mild or moderate to severe disease



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinical suspicion or evidence of SARS-CoV-2-infection on presentation in the ED and matching controls, based on demographics, underlying diseases and duration of hospital stay (i.e. one control per case, both in the same hospital).
Criteria

Inclusion Criteria:

  • Clinical suspicion or evidence of SARS-CoV-2-infection on presentation in the ED

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351854


Contacts
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Contact: Volker Burst, MD +4922147897222 volker.burst@uk-koeln.de
Contact: Victor Suarez, MD +4922147897222 victor.suarez@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Volker Burst, MD    +49(0)221 478 86285    volker.burst@uk-koeln.de   
Contact: Victor Suarez, MD       victor.suarez@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
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Responsible Party: Volker Burst, PD Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT04351854    
Other Study ID Numbers: ReCovER
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Emergencies
Disease Attributes
Pathologic Processes
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases