NCT04527497

Brief Summary

The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

December 15, 2023

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

August 20, 2020

Last Update Submit

December 14, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • convalescence/death

    has patient died or has patient recovered

    through study completion, an average of 2 months

Secondary Outcomes (2)

  • length of stay in the intensive care unit

    through study completion, an average of 2 months

  • length of stay in hospital

    through study completion, an average of 2 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who are inpatients at Bethanien Hospital and have a proven COVID-19 infection and who agree to participate in the study during the period from 01.08.2020 - 30.05.2021.

You may qualify if:

  • positive COVID-19 test result
  • Age \> 18 years

You may not qualify if:

  • Age \< 18 years
  • negative COVID-19 test result
  • lack of agreement
  • Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Winfried Randerath, Prof. Dr.

    Krankenhaus Bethanien Solingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 26, 2020

Study Start

August 1, 2020

Primary Completion

May 30, 2021

Study Completion

August 31, 2021

Last Updated

December 15, 2023

Record last verified: 2021-10

Locations

DE(1)