NCT04423003

Brief Summary

This is a combined study including a descriptive part about the preparations for COVID-19 and the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who required endoscopic intervention. Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3. Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 8, 2020

Last Update Submit

June 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • death in time of observation

    death in time of observation

    01.March 2020 to 5. May 2020

Interventions

All endoscopic interventions in COVID-19 positive tested patients were included

Eligibility Criteria

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

10 patients

You may qualify if:

  • patients with proven or suspected infections with SARS-CoV-2 infection, who required endoscopic interventions

You may not qualify if:

  • all other patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

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
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 9, 2020

Study Start

March 1, 2020

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations