NCT05150821

Brief Summary

To investigate the effects of lockdown in the Emergency Department in a tertiary health care hospital, Nuremberg, Germany.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

December 7, 2021

Last Update Submit

August 24, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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.

    through study completion, an average of 1 year

  • CDD

    clinical severity index of diverticulitis. Min 0 - max. 4

    through study completion, an average of 1 year

Study Arms (2)

experimental

patients during lockdown

control group

patients before lockdown

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study population will be patients of a teriary care clinic

You may qualify if:

  • Only patients who presented in the ED.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Radiology and Nuclear Medicine

Nuremberg, Bavaria, 90419, Germany

Location

Related Publications (5)

  • 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.

    PMID: 32387156BACKGROUND

  • Tam 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.

    PMID: 32367683BACKGROUND

  • Wexner 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.

    PMID: 32359223BACKGROUND

  • Morgan 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.

    PMID: 32343187BACKGROUND

  • Wang 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.

    PMID: 32347566BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med. Panagiota Manava, MD, Principal Investigator

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 9, 2021

Study Start

September 1, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)