Clinical Course and Treatment of COVID-19 Inpatients in H... | NCT04527497

Studies
Clinical Course and Treatment of COVID-19 Inpatients in Hospital

NCT04527497

Sponsor

Wissenschaftliches Institut Bethanien e.V

Status

Completed

Last Update Posted

Dec 15, 2023Actual

Enrollment

35Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

May 30, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Aug 20, 2020

First Submission Date that Met QC Criteria

Aug 24, 2020

First Posted Date

Aug 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients:

Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease?
Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
convalescence/death	has patient died or has patient recovered	through study completion, an average of 2 months

Secondary Outcomes

Measure	Description	Time Frame
length of stay in the intensive care unit	length of stay in the intensive care unit	through study completion, an average of 2 months
length of stay in hospital	length of stay in hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

positive COVID-19 test result
Age > 18 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried Randerath, Prof. Dr.	Krankenhaus Bethanien Solingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.		Solingen	North Rhine-Westphalia	42699	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided