Prospective Quality Register of Patients With Confirmed C... | NCT04345536

Studies
Prospective Quality Register of Patients With Confirmed Covid-19 at Oslo University Hospital

NCT04345536

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Nov 14, 2023Actual

Enrollment

2,519Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Norway

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

Nov 2023

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

Mar 15, 2020Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Nov 1, 2023Actual

First Submitted Date

Apr 5, 2020

First Submission Date that Met QC Criteria

Apr 12, 2020

First Posted Date

Apr 14, 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

Nov 13, 2023

Last Update Posted Date

Nov 14, 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

Covid-19 is a recently emerging infectious disease with a very large impact on health care world-wide. The disease is still poorly described. It is an urgent need for better clinical characteristics. A prospective, quality register is therefore established for increasing the knowledge about the disease, the covid patients and the prognosis.

Detailed Description

All patient hospitalized at Oslo University Hospital, Ullevål, is prospectively registered in the approved quality register. Background, clinical and paraclinical data is harvested and registered, as well as treatment and mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,519Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients hospitalized with confirmed Covid-19		All patients hospitalized with confirmed Covid-19

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality in hospitalized covid patients	3 month
Severe disease	Number of patients with severe disease	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed covid-19
hospitalized

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospitalized patients in a secondary and tertiary care University Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristian Tonby, MD	Oslo University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0424	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33403367	Derived	Holten AR, Nore KG, Tveiten CEVWK, Olasveengen TM, Tonby K. Predicting severe COVID-19 in the Emergency Department. Resusc Plus. 2020 Dec;4:100042. doi: 10.1016/j.resplu.2020.100042. Epub 2020 Oct 21.

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