Evaluation of the Safety and Outcomes of Outpatient Management With Mild to Moderate COVID-19 Pneumonia (PneumoCoV-Ambu)
Conditions: Covid19, Pneumonia
Sponsor: University Hospital, Geneva

Evaluation of the safety and outcomes of outpatient management 
with mild to moderate COVID-19 pneumonia (PneumoCoV-Ambu)
Swissethics Model
for the submission of "reuse with consent" projects in accordance with the HRA / ORH
Research plan/protocol in accordance with HRO :
Reuse of biological materials and personal health-related data for research purposes in 
accordance with ss. 32 and 33 HRA
Title of project
Evaluation of the safety and outcomes of outpatient management with mild to moderate COVID-
19 pneumonia (PneumoCoV-Ambu).
Name and Adress of project manager
Dr Chloé Chevallier Lugon, Chief resident
Cluse-Roseraie Louise Morier, rue Gabriel-Perret-Gentil 4, 1205 Genève 
079 55 34609, chloe.lugon@hcuge.ch 
Dr. Olivia Braillard, Attending physician
Cluse-Roseraie Louise Morier, rue Gabriel-Perret-Gentil 4, 1205 Genève 
022 372 96 77, olivia.braillard@hcuge.ch 
Dr. Julien Salamun, Attending physician
Cluse-Roseraie Louise Morier, rue Gabriel-Perret-Gentil 4, 1205 Genève 
022 372 51 06, julien.salamun@hcuge.ch
Promotor
Dr. Hervé Spechbach, Attending physician
Cluse-Roseraie Louise Morier, rue Gabriel-Perret-Gentil 4, 1205 Genève
022 372 95 22, herve.spechbach@hcuge.ch
Confirmation from project management and (if applicable) the promotor
By my signature, I certify that all the information contained in this research plan is 
accurate and I undertake to comply with this information as well as with national 
legislation relating in particular to data protection.
Project manager :
Date 24.06.2020
Signature
Promotor:
Date 24.06.2020
Signature
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Evaluation of the safety and outcomes of outpatient management 
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Abbreviations
COVID-19
Coronavirus disease 2019
NIH: 
National Institute Health
CDC
Center of Disease Control
HUG
Geneva University Hospital
DPI
Computerized Patient Record
LRH
Law on Research on Human Beings
ORH
Ordinance on Research on Human Beings
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
CURB 65
Confusion, Urea>7umol/l, Respiration rate>30/min, Blood 
Pressure<90/50mmHg, age >65
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Evaluation of the safety and outcomes of outpatient management 
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1. Context
Severe  Acute  Respiratory  Coronavirus  2  (SARS-CoV-2)  is  a  new  coronavirus  strain  that
emerged from Wuhan, China, at the end of 2019. Subsequently, the infection rapidly spread
throughout the world and was declared pandemic by the WHO on 11 March 2020. The virus
continues to propagate worldwide, infecting more than 6M people and causing more than
390’000 deaths1. This new disease challenges health systems all over the world and represents
an  overwhelming  cause  of  hospitalization.  The  spectrum  of  COVID-19  ranges  from
asymptomatic  infection  through  mild  respiratory  tract  symptoms,  to  moderate  and  severe
pneumonia. The disease can also manifest through other non-respiratory symptoms, however
we will not be describing them in this current protocol as our focus is on respiratory symptoms. 
We can find many guidelines for hospitalized patients, but in an outpatient setting, our research
did not find a lot of data or guidelines, especially for SARS-CoV-2 pneumonia. In the context of
COVID-19,  health  institution  and  governing  bodies  such  as  the  NIH  and  CDC  tend  to
categorizes SARS-CoV-2 symptoms to guide treatment and follow-up. Patients are divide into
five categories2: 
- Asymptomatic or Presymptomatic Infection: test positive for SARS-CoV-2 but have no
symptoms
- Mild Illness: any of various signs and symptoms (e.g., fever, cough, sore throat, malaise,
headache, muscle pain) without shortness of breath, dyspnoea, or abnormal imaging
- Moderate Illness: evidence of lower respiratory disease by clinical assessment or imaging
and a saturation of oxygen (SaO2) >93% on room air at sea level.
- Severe Illness: respiratory frequency (RF) >30 breaths per minute, SaO2 ≤93% on room
air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen
(PaO2/FiO2) <300, or lung infiltrates >50% seen on thoracic imaging 
- Critical Illness: respiratory failure, septic shock, and/or multiple organ dysfunction
For patients with moderate or more severe illness, the NIH and CDC recommend admission to
a health care facility for close observation2. This model was not adopted worldwide, as national
and/or medical centers developed their own strategies. To our knowledge, there are no studies
involving SARS-CoV-2 outpatients with moderate pneumonia.
As for other bacterial and viral pneumonia, several scores defining an outpatient setting are
successfully used; we choose to adapt the CURB-653 score in the context of SARS-CoV-2
pneumonia. The algorithm included a medical evaluation and paraclinical tests at baseline to
ensure the absence of hospitalization criteria4  (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). We also took into account
the social situation of patients in order to ensure effective isolation measures and support at
home. If the management chosen was to keep the patient in an outpatient setting, a follow-up
was organised  (figure 1): follow-up could be done by phone or by the patient’s primary care
physician or by an outpatient general medicine consultation at the HUG. For on-site visits, a
specific track was established to avoid contact with other patients or healthcare workers 
The purpose of this study is to evaluate our strategy for outpatients SARS-CoV-2 moderate
pneumonia management in terms of efficacy and patient safety. Our ultimate goal is to validate
our first wave management strategy in order to support our 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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Evaluation of the safety and outcomes of outpatient management 
with mild to moderate COVID-19 pneumonia (PneumoCoV-Ambu)
Figure 1: Moderate pneumonia outpatient management algorithm5
2. Objective 
Validation of our strategy in terms of safety and efficacy for the treatment of moderate SARS-
CoV-2 pneumonia
3. Origin of data and material
We focused on patients 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, we have created an aftercare ambulatory unit, open 5/7 days. We were
able  to  conduct  64  consultations  between  April  2  and  May  5,  2020.  Every  patients  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 our 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. We 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).  We will  coordinate  with  the  unified  HUG  database,  which  is  in  process  by Prof.
Christian Lovis.  
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Evaluation of the safety and outcomes of outpatient management 
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4. Inclusion Criterias
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.
5. Exclusion Criterias 
Patients with hospitalization criteria4 
Refusal to consent documentation found in the computerized patient record or oral refusal
consent during follow up call. 
6. Information and consent of participants
All data are from our daily clinical activity with patients with SARS-CoV-2 pneumonia who visited
the Ambulatory Care Unit between April 2, 2020 and May 5, 2020. The Covicare team obtained
their consent by telephone for the use of the data at the time of diagnosis. A form was sent to
them by message to validate their consent in writing (see attached file name “Consentement à
l'utilisation des données en lien avec le COVID19 à des fins de recherche”.) Moreover, since the
beginning of the outbreak, the HUG screening and emergency sites contain an informative
poster mentioning that patient clinical data can be used and collected in clinical studies on
COVID-19. Any patient who refuses to allow their data to be used must inform the health care
provider at the time of care, and this refusal is insert into DPI. Such patients will be excluded
from the study.
7. Scientific methodology 
We want to elaborate a retrospective and prospective cohort study. 
The statistical analyses will be descriptive only. Given the small sample size of patients, no
statistical measures of association will be performed. The data collection period is from April 2
to May 5, 2020. The satisfaction study will be prospective, within the 3 months after diagnosis. 
The primary outcome will be secondary hospitalization(s) or death COVID-19 related, until 30 to
60 days from diagnosis
Secondary outcomes will be 
- number  of  unexpected  COVID-19  related  outpatient  visits  until  day  30  to  60  from
diagnosis, 
- severity of COVID-19 disease on a 7-points ordinal scale at 30 to 60 days after diagnosis
of  SARS-CoV-2  (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),
- patient satisfaction with management strategies 
- estimation of saved costs compared with a strategy of hospitalization of all COVID-19
related pneumonia cases.
8. Obligation to announce 
A change in the study’s orientation or of the elements mentioned in the decision must be
announced beforehand to the competent ethics committee. 
9. Data protection: coding and preservation 
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Evaluation of the safety and outcomes of outpatient management 
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Removing direct and indirect identifiers will coded data extracted from the DPI. Record ID will
be created using a number (1 to 100 for example). This record ID will be reported on the paper
survey filled by physicians. Anonymized data will be stored in Microsoft Excel format, protected
with a password and on a HUG server, on the responsibility of Dr Chloé Chevallier Lugon.
10. Procedure concerning non coded data 
Data from the physician survey will be coded by Dr Chloé Chevallier Lugon and matched with
coded data using the record ID. Coded data will be stored in Excel format, protected with a
password and on a HUG server, on the responsibility of Dr Chloé Chevallier Lugon.
11. Data storage 
Anonymized coded data will be stored in Excel format, protected with a password and on a
HUG server, on the responsibility of Dr Chloé Chevallier Lugon.
Only Dr Chloé Chevallier Lugon can modify the protected Excel file. At each modification, a
PDF extract will be made, and named after the date and the initials of the contributor. Paper
surveys will be stored in a locked drawer in Dr Chloé Chevallier Lugon HUG office.
12. Storage time 
Once the study is complete, record ID and paper surveys will be destroyed. Data will be kept for
10 years.
13. Ethical and regulatory requirements
This study meets the regulatory requirements of the LRH and the ORH. The prerequisite for
carrying out the project is approval by the competent ethics committee.
14. Funding / publication / declaration of interests 
This project does not have specific funding. 
There is no conflict of interest.
Durée de conservation
15. Bibliographie
1. World Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. 11 
May 2020. Disponible sur : https://covid19.who.int/
2.  National Institute of Health (NIH),COVID-19 Treatment guideline – Management of 
person with COVID-19.  
Disponible sur: https://covid19treatmentguidelines.nih.gov/overview/management-of-
covid-19/
3.  Lim WS, van der Eerden MM, Laing R, Boersma WG, Karalus N, Town GI, Lewis 
 
 
SA, Macfarlane JT. 
 
 Defining community acquired pneumonia severity on presentation to
 
 
hospital: an international derivation and validation study. 
 
 Thorax 2003;58(5):377-82
 
 
4. Recommandations HUG Groupe Guidelines COVID : Critères d’hospitalisation des 
patients COVID-19 suspectés ou confirmés
Disponible sur : https://www.hug-ge.ch/coronavirus/recommandations-pour-
professionnels-sante
5. Recommandations HUG Groupe Guidelines COVID: Prise en charge ambulatoire des
patients suspects de pneumonie à SARS-CoV-2 
 Disponible sur : https://www.hug-ge.ch/coronavirus/recommandations-pour-
professionnels-sante
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