National Survey of Symptoms of People Aged 70 and Overs D... | NCT04343781

Studies
National Survey of Symptoms of People Aged 70 and Overs Diagnosed With COVID-19

NCT04343781

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

353Actual

Phase

Not provided

Conditions

SARS-CoV-2
COVID-19

Interventions

observation

Countries

France

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

Apr 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 22, 2020Actual

Primary Completion Date

Apr 5, 2020Actual

Completion Date

Apr 5, 2020Actual

First Submitted Date

Apr 9, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 13, 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

Jun 12, 2020

Last Update Posted Date

Jun 16, 2020Actual

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

Cross-sectional study based on a French national survey aimed to described and identify the most frequent symptoms of COVID-19 older patients.

Detailed Description

This cross-sectional survey was initiated and conducted by the French Society of Geriatrics and Gerontology. A standardized questionnaire was emailed to 1600 geriatrician members of the French Society of Geriatrics and Gerontology throughout France between March 22, 2020 and April 5, 2020. Geriatricians were asked to complete the survey for their last 10 patients infected by the SARS-CoV-2. The study was declared to the Commission Nationale de l'Informatique et des Libertés (CNIL) under the number ar20-0031v1.

For each patient, demographic characteristics (age, gender, residence place, care place, autonomy according to the Groupe Iso Ressource (GIR)), medical history (presence of major neurocognitive disorder, hypertension, diabetes, asthma or chronic obstructive pulmonary disease (COPD), heart pathology, severe renal failure with a clearance of creatinine under 30ml/min, solid or liquid cancer) were collected. The symptoms within de 72 hours of the actual disease were also collected for each patient including geriatric syndromes (fall, hypoactive or hyperactive delirium, altered general status, altered conscience), general symptoms (temperature, blood pressure), respiratory symptoms (cough, polypnea), ear nose and throat (ENT) symptoms (rhinorrhea, odynophagia, otalgia, conjunctivitis, ageusia or dysgeusia, anosmia), digestive symptoms (diarrhea, nausea or vomiting), and blood formula modification (leucopenia (with count if available), lymphopenia (with count if available), thrombopenia (with count if available).

Procedure Data were collected by the physician who was in charge of the patient between March 22, 2020 and April 5, 2020.

Given the main objective of the study was only descriptive, no calculation was required concerning the number of subjects to include in the study.

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

353Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	observation of clinical symptoms related to COVID-19 disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptoms of COVID-19 in older patients	description and identification of symptoms presented by older patients with confirmed COVID-19	at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed COVID-19 defined by a positive RT-PCR to SARS-CoV-2

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

all older French patients infected by SARS-CoV-2

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cédric Annweiler, M.D., Ph.D.	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital		Angers		49933 cedex 9	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32556328	Derived	Annweiler C, Sacco G, Salles N, Aquino JP, Gautier J, Berrut G, Guerin O, Gavazzi G. National French Survey of Coronavirus Disease (COVID-19) Symptoms in People Aged 70 and Over. Clin Infect Dis. 2021 Feb 1;72(3):490-494. doi: 10.1093/cid/ciaa792.

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

ID	Term
D008722	Methods
D008919	Investigative Techniques