COVID-19NCT05150821
Impact of Covid-19 in the Emergency Department
An observational study of COVID-19, run by Dr. Panagiota Manava at 1 site in Germany.
Trial summary
To investigate the effects of lockdown in the Emergency Department in a tertiary health care hospital, Nuremberg, Germany. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 599 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 1 Jul 2023
- 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: the study population will be patients of a teriary care clinic
Who may be able to join
- Only patients who presented in the ED.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Radiology and Nuclear Medicine
Nuremberg, Bavaria, 90419
About this study
Official title: Impact of Covid-19 in the Emergency Department in a Tertiary Care Hospital, Nuremberg-Germany
To investigate the effects of lockdown in the Emergency Department in a tertiary health care hospital, Nuremberg, Germany.
Read the detailed description
To investigate the effect of the first lockdown caused by the pandemic of Covid-19 in a tertiary health care hospital. Klinikum Nuremberg is one of the largest tertiary health care hospitals in Germany with two locations in Nuremberg. In the north department, around 150 outcome patients visit the Emergency Department every day.
During the pandemic in 2020 the capacities of the hospitals were saved for the patients with Covid-19. A decrease of patients presented in the ED was noticed. Controlling system and patient management provided the number of cases and correlated with the same period of time one year ago, before the pandemic.
For the classification of severity of diseases, different clinical diseases with severity scores were analyzed. Following diseases and scores were evaluated:
Pancreatitis -- > ranson score; ACS (acute coronary syndrome) --> Grace-Score; Pulmonary Embolism -- > sPESI (simplified Pulmonary Embolism Severity Index); Diverticulitis --> CDD (Classification of Diverticular Disease); Pneumonia -> crb65 (Confusion- Respiratory rate- Blood pressure- age ≥ 65 years);
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental | patients during lockdown | |
| control group | patients before lockdown |
What is being measured
The primary outcome is the main question the study is designed to answer.
ranson score
clinical severity index of pancreatitis. Estimates mortality of patients with pancreatitis, based on initial and 48-hour lab values. Min. 0 - Max. 11 points.
Measured: through study completion, an average of 1 year
Grace-Score
clinical severity index of ACS. Estimates admission untill 6 month mortality for patients with acute coronary syndrome. 108 points: low risk. Over 141-372 points: high risk.
Measured: through study completion, an average of 1 year
sPESI
clinical severity index of pulmonary embolism. Predicts 30-day outcome of patients with pulmonary embolism. Min 0 points- max. 6 points
Measured: through study completion, an average of 1 year
crb65
The CRB-65-score is a clinical score that is used to estimate the severity of community-acquired pneumonias. The score corresponds to the statistical probability of patients dying because of pneumonia. Min 0 points - highest score 4 points.
Measured: through study completion, an average of 1 year
CDD
clinical severity index of diverticulitis. Min 0 - max. 4
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Sep 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Panagiota Manava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Panagiota Manava, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150821
- Sponsor's protocol ID
- IC_2021_KNN
- Status last verified
- Aug 2023
- First submitted
- 7 Dec 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwee J, Chiew J, Sechachalam S. The Impact of Coronavirus Disease 2019 (COVID-19) on the Practice of Hand Surgery in Singapore. J Hand Surg Am. 2020 Jun;45(6):536-541. doi: 10.1016/j.jhsa.2020.04.023. Epub 2020 Apr 29.
PubMed 32387156Tam CF, Cheung KS, Lam S, Wong A, Yung A, Sze M, Fang J, Tse HF, Siu CW. Impact of coronavirus disease 2019 (COVID-19) outbreak on outcome of myocardial infarction in Hong Kong, China. Catheter Cardiovasc Interv. 2021 Feb 1;97(2):E194-E197. doi: 10.1002/ccd.28943. Epub 2020 May 5.
PubMed 32367683Wexner SD, Cortes-Guiral D, Gilshtein H, Kent I, Reymond MA. COVID-19: impact on colorectal surgery. Colorectal Dis. 2020 Jun;22(6):635-640. doi: 10.1111/codi.15112. Epub 2020 May 22.
PubMed 32359223Morgan C, Ahluwalia AK, Aframian A, Li L, Sun SNM. The impact of the novel coronavirus on trauma and orthopaedics in the UK. Br J Hosp Med (Lond). 2020 Apr 2;81(4):1-6. doi: 10.12968/hmed.2020.0137. Epub 2020 Apr 10.
PubMed 32343187Wang Y, Han W, Pan L, Wang C, Liu Y, Hu W, Zhou H, Zheng X. Impact of COVID-19 on blood centres in Zhejiang province China. Vox Sang. 2020 Aug;115(6):502-506. doi: 10.1111/vox.12931. Epub 2020 Apr 29.
PubMed 32347566
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 in the Emergency Department in a Tertiary Care Hospital, Nuremberg-Germany
- ClinicalTrials.gov ID
- NCT05150821
- Acronym / sponsor ID
- IC_2021_KNN
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Dr. Panagiota ManavaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of lockdown in the Emergency Department in a tertiary health care hospital, Nuremberg, Germany.
Detailed description
To investigate the effect of the first lockdown caused by the pandemic of Covid-19 in a tertiary health care hospital. Klinikum Nuremberg is one of the largest tertiary health care hospitals in Germany with two locations in Nuremberg. In the north department, around 150 outcome patients visit the Emergency Department every day.
During the pandemic in 2020 the capacities of the hospitals were saved for the patients with Covid-19. A decrease of patients presented in the ED was noticed. Controlling system and patient management provided the number of cases and correlated with the same period of time one year ago, before the pandemic.
For the classification of severity of diseases, different clinical diseases with severity scores were analyzed. Following diseases and scores were evaluated:
Pancreatitis -- > ranson score; ACS (acute coronary syndrome) --> Grace-Score; Pulmonary Embolism -- > sPESI (simplified Pulmonary Embolism Severity Index); Diverticulitis --> CDD (Classification of Diverticular Disease); Pneumonia -> crb65 (Confusion- Respiratory rate- Blood pressure- age ≥ 65 years);
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | – | –patients during lockdown |
| control group | – | –patients before lockdown |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study population will be patients of a teriary care clinic
Key inclusion criteria (1 listed)
- Only patients who presented in the ED.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ranson score
Time frame: through study completion, an average of 1 year
clinical severity index of pancreatitis. Estimates mortality of patients with pancreatitis, based on initial and 48-hour lab values. Min. 0 - Max. 11 points.
Grace-Score
Time frame: through study completion, an average of 1 year
clinical severity index of ACS. Estimates admission untill 6 month mortality for patients with acute coronary syndrome. 108 points: low risk. Over 141-372 points: high risk.
sPESI
Time frame: through study completion, an average of 1 year
clinical severity index of pulmonary embolism. Predicts 30-day outcome of patients with pulmonary embolism. Min 0 points- max. 6 points
crb65
Time frame: through study completion, an average of 1 year
The CRB-65-score is a clinical score that is used to estimate the severity of community-acquired pneumonias. The score corresponds to the statistical probability of patients dying because of pneumonia. Min 0 points - highest score 4 points.
CDD
Time frame: through study completion, an average of 1 year
clinical severity index of diverticulitis. Min 0 - max. 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 32387156Hwee J, Chiew J, Sechachalam S. The Impact of Coronavirus Disease 2019 (COVID-19) on the Practice of Hand Surgery in Singapore. J Hand Surg Am. 2020 Jun;45(6):536-541. doi: 10.1016/j.jhsa.2020.04.023. Epub 2020 Apr 29.
- Background: PubMed 32367683Tam CF, Cheung KS, Lam S, Wong A, Yung A, Sze M, Fang J, Tse HF, Siu CW. Impact of coronavirus disease 2019 (COVID-19) outbreak on outcome of myocardial infarction in Hong Kong, China. Catheter Cardiovasc Interv. 2021 Feb 1;97(2):E194-E197. doi: 10.1002/ccd.28943. Epub 2020 May 5.
- Background: PubMed 32359223Wexner SD, Cortes-Guiral D, Gilshtein H, Kent I, Reymond MA. COVID-19: impact on colorectal surgery. Colorectal Dis. 2020 Jun;22(6):635-640. doi: 10.1111/codi.15112. Epub 2020 May 22.
- Background: PubMed 32343187Morgan C, Ahluwalia AK, Aframian A, Li L, Sun SNM. The impact of the novel coronavirus on trauma and orthopaedics in the UK. Br J Hosp Med (Lond). 2020 Apr 2;81(4):1-6. doi: 10.12968/hmed.2020.0137. Epub 2020 Apr 10.
- Background: PubMed 32347566Wang Y, Han W, Pan L, Wang C, Liu Y, Hu W, Zhou H, Zheng X. Impact of COVID-19 on blood centres in Zhejiang province China. Vox Sang. 2020 Aug;115(6):502-506. doi: 10.1111/vox.12931. Epub 2020 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Dr. Panagiota Manava 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 Aug 2023. 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?
ranson score (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150821, which also lists 5 linked publications.
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 Aug 2023.