NCT04542044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

September 2, 2020

Last Update Submit

September 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Secondary hospitalization(s) or death COVID-19 related

    30 to 60 days from diagnosis

Secondary Outcomes (3)

  • severity of COVID-19 disease

    30 to 60 days from diagnosis

  • patient satisfaction with management strategies

    30 to 60 days from diagnosis

  • Saved costs

    30 days

Interventions

Data collected with a cohorte of SARS-CoV-2 pneumonia in an outpatient basis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Switzerland

Location

MeSH Terms

Conditions

COVID-19Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief resident

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 9, 2020

Study Start

April 2, 2020

Primary Completion

May 5, 2020

Study Completion

June 30, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations