Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)

description: Percentage of participants who has died or needed non-invasive or mechanical ventilation
by day 4 (WHO clinical progression scale > 5). A patient with new do-not-resuscitate
order at day 4 will be considered as with a score > 5.
WHO progression scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic;
Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4
Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow:
6 Intubation and Mechanical ventilation, pO2/FIO2≥150 OR SpO2/FIO2≥200: 7 Mechanical
ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3
microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine
>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
time_frame: 4 days

Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline)

description: Survival without needs of ventilator utilization (including non invasive ventilation and
high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or
death. Thus, events considered are needing ventilator utilization (mechanical or
non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate
(DNR) order (if given after the inclusion of the patient) will be considered as an event
at the date of the DNR.
time_frame: Day 1 to Day 14

Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline)

description: Results are presented as the percentage not improved, so that an effective treatment
would be associated with a decrease in percentage
Scale:
Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic;
Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4
Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow:
6 Intubation and Mechanical ventilation, pO2/FIO2≥150 OR SpO2/FIO2≥200: 7 Mechanical
ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3
microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine
>0.3 microg/kg/min), OR Dialysis OR ECMO: 9
time_frame: 4 days

Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)

description: Cumulative incidence of successful tracheal extubation (defined as duration extubation >
48h) at day 14 if patients have been intubated before day 14 ; or removal of Non Invasive
Ventilation or high flow (for > 48h) if they were included under oxygen by Non Invasive
Ventilation or High flow (score 6) and remained without intubation. Death or new
do-not-resuscitate order (if given after the inclusion of the patient) will be considered
as a competing event.
time_frame: Day 1 to Day 14