AzTrials
AzTrials

Corona Virus InfectionReCovERNCT04351854

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

An observational study of Corona Virus Infection and SARS-CoV 2, run by University of Cologne at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Corona Virus Infection, SARS-CoV 2
What is being tested?
Retrospective data collection
How many people
500 participants
Where
1 siteGermany
Study dates
20 Apr 2020to 31 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University Hospital of Cologne

    Cologne, 50937

Other trials in Germany

About this study

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.

Being tested
Retrospective data collection
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrospective data collectionOther

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

Study groups in NCT04351854
Study groupRoleWhat they receive
Patients with SARS-CoV-2-infectionPatients with clinical suspicion or evidence of SARS-CoV-2-infection on presentation in the ED
Receives: Other: Retrospective data collection
Control groupParticularly, 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.
Receives: Other: Retrospective data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (2)
  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

    Measured: 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start20 Apr 2020
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04351854
Sponsor's protocol ID
ReCovER
Acronym
ReCovER
Status last verified
May 2022
First submitted
16 Apr 2020
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Corona Virus Infection and SARS-CoV 2, run by University of Cologne at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in