- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542044
Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia (PneumoCoV-Ambu)
Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia (PneumoCoV-Ambu)
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Geneva, Switzerland
- Geneva University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary hospitalization(s) or death COVID-19 related
Time Frame: 30 to 60 days from diagnosis
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30 to 60 days from diagnosis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severity of COVID-19 disease
Time Frame: 30 to 60 days from diagnosis
|
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),
|
30 to 60 days from diagnosis
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patient satisfaction with management strategies
Time Frame: 30 to 60 days from diagnosis
|
Satisfaction Survey of outpatient management
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30 to 60 days from diagnosis
|
Saved costs
Time Frame: 30 days
|
estimation of saved costs compared with a strategy of hospitalization of all COVID-19 related pneumonia cases.
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCER2020-01518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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