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

Covid19 Clinical Trial

— PneumoCoV-Ambu  

Official title:

Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia (PneumoCoV-Ambu)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542044
• Other study ID #: CCER2020-01518
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

Other:
• management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia
Data collected with a cohorte of SARS-CoV-2 pneumonia in an outpatient basis

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary hospitalization(s) or death COVID-19 related		30 to 60 days from diagnosis
Secondary	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),	30 to 60 days from diagnosis
Secondary	patient satisfaction with management strategies	Satisfaction Survey of outpatient management	30 to 60 days from diagnosis
Secondary	Saved costs	estimation of saved costs compared with a strategy of hospitalization of all COVID-19 related pneumonia cases.	30 days