Outcomes in Hospitalized Older Patients With COVID-19 | NCT04385212

Studies
Outcomes in Hospitalized Older Patients With COVID-19

NCT04385212

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

May 12, 2020Actual

Enrollment

230Actual

Phase

Not provided

Conditions

Coronavirus Infection
Sars-CoV2
Elderly Infection
Old Age; Debility

Interventions

Not provided

Countries

Switzerland

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

May 2020

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 13, 2020Actual

Primary Completion Date

Apr 14, 2020Actual

Completion Date

Apr 14, 2020Actual

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

May 8, 2020

First Posted Date

May 12, 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

May 8, 2020

Last Update Posted Date

May 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christine Serratrice, MD, Principal Investigator, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

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

In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.

Detailed Description

Not provided

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

230Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the relative contributions of comorbidities on intra-hospitalized death	We measure functional score of comorbidities	1 month

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the relative contributions of functional characteristics on intra-hospitalized death	We measure Functional Independence Measure scale	1 month
To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of COVID-19, defined by a positive polymerase chain reaction (PCR) test for SARS-CoV-2 detection, obtained by a nasopharyngeal swab or sputum sample.
Or patients with negative virus detection in the PCR test, but with a high clinical suspicion will also be considered with COVID-19.

Exclusion Criteria:

- Presence of document indicating a refusal to participate in a research study.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All the patients hospitalized in our geriatrics department with Sars-Cov-2 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rehabilitation and Geriatrics		Geneva		1256	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D000073496	Frailty

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided