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

• ClinicalTrials.gov Identifier: NCT04542044
• Recruitment Status: Completed
• First Posted: September 9, 2020
• Last Update Posted: September 9, 2020
• Sponsor: University Hospital, Geneva
• Information provided by (Responsible Party): Chevallier-Lugon Chloé, University Hospital, Geneva

Study Description

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.

Condition or disease	Intervention/treatment
Covid19; Pneumonia	Other: management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia

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 Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia (PneumoCoV-Ambu)
• Actual Study Start Date: April 2, 2020
• Actual Primary Completion Date: May 5, 2020
• Actual Study Completion Date: June 30, 2020

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. Secondary hospitalization(s) or death COVID-19 related [ Time Frame: 30 to 60 days from diagnosis ]

Secondary Outcome Measures :

1. 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),
2. patient satisfaction with management strategies [ Time Frame: 30 to 60 days from diagnosis ]
   Satisfaction Survey of outpatient management
3. Saved costs [ Time Frame: 30 days ]
   estimation of saved costs compared with a strategy of hospitalization of all COVID-19 related pneumonia cases.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

Switzerland

Geneva University Hospital

Geneva, Switzerland

Sponsors and Collaborators

University Hospital, Geneva

  Study Documents (Full-Text)

Documents provided by Chevallier-Lugon Chloé, University Hospital, Geneva:

Study Protocol  [PDF] June 24, 2020

More Information

• Responsible Party: Chevallier-Lugon Chloé, Chief resident, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT04542044
• Other Study ID Numbers: CCER2020-01518
• First Posted: September 9, 2020
• Last Update Posted: September 9, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia; Respiratory Tract Infections; Infections; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases