Evaluation of the Safety and Outcomes of Outpatient Manag... | NCT04542044

Studies
Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia

NCT04542044

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Sep 9, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Covid19
Pneumonia

Interventions

management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 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

Apr 2, 2020Actual

Primary Completion Date

May 5, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Sep 2, 2020

First Submission Date that Met QC Criteria

Sep 7, 2020

First Posted Date

Sep 9, 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

Sep 7, 2020

Last Update Posted Date

Sep 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chevallier-Lugon Chloé, Chief resident, 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

The purpose of this study is to evaluate the strategy of investigators for outpatients SARS-CoV-2 moderate pneumonia management in terms of efficacy and patient safety. The investigators ultimate goal is to validate first wave management strategy in order to support the investigators future approach in the event of a second wave, and spare the hospital resources by safely keeping at home as many patients as possible.

Detailed Description

The investigators focused on participants consulting in the emergency department at the HUG who remained in an outpatient setting, with pneumonia and moderate illness, defined by individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SaO2) >93% on room air and no other hospitalization criteria (CURB 65 score below 2points).

For patients' follow-up, the investigators have created an aftercare ambulatory unit, open 5/7 days. The investigators were able to conduct 64 consultations between April 2 and May 5, 2020. Every participant had suspected or confirmed SARS-CoV-2 pulmonary tract infection.

The follow-up data was entered into DPI (patient's medical record at HUG) on a specific consultation form. Patients followed in the investigators consultation were contacted between 30 and 60 days after diagnosis by the Covicare team. The Covicare team is call-center composed of medical students and primary care physicians who remotely followed patients with COVID-19 by calling them by phone or telemedicine every day or every other day depending on patients' needs and health status. The investigators will export data from RedCap concerning post-hospitalization, satisfaction survey on our care and oral consent for use of data (ARGOS study CCER number 2020-01273).

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

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia	Other	Data collected with a cohorte of SARS-CoV-2 pneumonia in an outpatient basis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Secondary hospitalization(s) or death COVID-19 related		30 to 60 days from diagnosis

Secondary Outcomes

Measure	Description	Time Frame
severity of COVID-19 disease	severity of COVID-19 disease on a 7-points ordinal scale (1: not hospitalized, no limitation of activities; 2: not hospitalized, limitation of activities; 3: hospitalized, not requiring supplementary oxygen; 4: hospitalized, requiring supplementary oxygen; 5: hospitalized, on non-invasive mechanical ventilation; 6: hospitalized, on invasive mechanical ventilation or ECMO; 7: death),

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All persons with suspected or confirmed SARS-CoV-2 pneumonia who consulted in the emergency department of the HUG without criteria for hospitalization4 (Pneumonia with CURB-65 >= 2 or new O2 dependency or increased O2 requirements or sustained respiratory rate≥20 min or decompensated comorbidity or major alteration of the general state) and who have been scheduled for outpatient follow-up in HUG.

Exclusion Criteria:

Patients with hospitalization criteria
Refusal to consent documentation found in the computerized patient record or oral refusal consent during follow up call.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with SARS-CoV-2 pneumonia without hospitalization criteria at primary consultation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospital		Geneva			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 24, 2020	Sep 7, 2020	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011014	Pneumonia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided