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Completed

NCT Number: NCT04542044

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital

Geneva, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Secondary hospitalization(s) or death COVID-19 related

    Time frame: 30 to 60 days from diagnosis

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: PneumoCoV-Ambu

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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