ClinicalTrials.gg
CompletedNCT04351854ReCovERUpdated May 25, 2022

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

An observational study in Corona Virus Infection and SARS-CoV 2, sponsored by University of Cologne. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by University of Cologne · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Sex
All
01

Study 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.

Read the detailed description

Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. It is the ED where crucial diagnostic and therapeutic steps are taken and where the decision for admission or discharge is made. As of now, the effectiveness and value of these initial measures and decisions are unclear. With still raising numbers of infections despite regulatory constraints in place, there is an urgent need to develop valid decision trees on how to treat patients suspected with COVID-19 in the ED.

Apart from the already described risk factors little is known about if and to which degree an infection with COVID-19 itself predisposes to other acute conditions (e.g. myocarditis, myocardial infarction or stroke). We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED.

Not all patients seek medical consultation at the very beginning of symptoms. 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. For example: an immunocompromised patient who presents with mild symptoms at a very early stage of COVID-19 would probably be deemed more at risk than the same patient who reports mild symptoms without progression for a duration of several weeks.

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. It will also help to identify the need for capacities in ambulatory care. COVID-19 Patients with mild or moderate symptoms can remain in quarantine at home. This would not only disburden hospitals but would also lower the risk for previously uninfected patients otherwise having to share rooms and wards with them.

Confirming the diagnosis There is uncertainty with regard to the best initial diagnostic in COVID-19 patients. Diagnostic tool of choice is a low-dose CT-scan of the thorax, which will detect typical radiologic signs of COVID-19 (ground-glass-opacities, bilateral consolidations and "crazy paving") with a high sensitivity, and in some cases even before onset of clinical symptoms. However, these features are also seen in other viral pneumonias and specificity reaches only 25%. Moreover, a CT-scan might not be available 24/7 in all hospitals, is time-consuming and exposes radiologic personnel to the risk of infection. Additionally, as is described later, many patients present with severe hypoxemia, a situation in which they might not be able to lie in a supine position in the CT-scanner. The role of lung ultrasound (LUS) in detection of COVID-19 has not been examined properly so far.

Testing for COVID-19 usually is done using an oral swab (or expectorated sputum) and real-time PCR (RT-PCR) after a clinical suspicion based on different parameters and/or after visits of the patient to regions with high prevalence of SARS-CoV-2. The sensitivity of this method has not been systematically evaluated, however, false-positive, as well as false-negative results have been reported. Moreover, there are sometimes contradictory results of RT-PCR and CT-scan. The registry will be used to collect and compare diagnostic data from radiological exams as well as RT-PCR-testing.

Many COVID-19 patients present with shortness of breath and hypoxemia. Physicians have used different therapeutic approaches including high-flow oxygen (HFNC), non-invasive ventilation or intubation and mechanical ventilation. While a trial with non-invasive methods is deemed safe and adequate by most experts, others have raised concerns and advocate early intubation and invasive ventilation in COVID-19. Participants of the registry will be asked to state the method of oxygenation/ventilatory support that was initiated in the ED.

Admission vs. discharge As has already been laid out, patients with COVID-19 exhibit symptoms of different severity. It is neither possible nor would it be reasonable to hospitalize every patient in which the condition is suspected or confirmed. Unfortunately, there are no diagnostic markers or laboratory cut-offs that help decide if a COVID-19 patient who presents to the ED has to be hospitalized or can be safely managed in ambulatory care. Our goal is to gather information of outcomes in both hospitalized and discharged patients and to compare this data with epidemiological, clinical, laboratory and radiologic data from the date of their visit to the ED.

The ED is the first contact to a hospital. Diagnostic and therapeutic measures from patients who are hospitalized due to the severity of their disease will be analyzed as well as complications or death during hospitalization. The duration of hospitalization will be analyzed and compared to the initial clinical picture.

02

Conditions studied

  • Corona Virus Infection
  • SARS-CoV 2
03

In context

Coronavirus Infections

952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 500 is above the median of 300 across 348 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRetrospective data collection

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  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

    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

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

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

    Time frame: 6 months

07

Study locations

1 site
  • University Hospital of Cologne
    Cologne, 50937, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in Jan 2022, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2020
First posted
Apr 17, 2020
StartActual
Apr 20, 2020
Primary completionActual
Jan 31, 2022
CompletionActual
Jan 31, 2022
Last update
May 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04351854
Responsible party
Volker Burst (Prof. Dr. med., University of Cologne) — Principal investigator
First posted
Apr 17, 2020
Start date
Apr 20, 2020
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
May 25, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion