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

NCT04351854 | Completed

• 1 other identifier: ReCovER
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; SARS-CoV 2

Outcome Measures

Primary Outcomes (1)

• Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

  Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.

  6 months

Secondary Outcomes (2)

• 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

  6 months

• Identification of the ratio of patients with mild or moderate to severe disease

  6 months

Study Arms (2)

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

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

Interventions

Retrospective data collection OTHER

Retrospective data collection to identify predicting factors in the clinical picture of COVID-19 patients presenting to the ED.

Control group; Patients with SARS-CoV-2-infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 17, 2020
• Study Start: April 20, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)