NCT04344730.

Study name	Dexamethasone and oxygen support strategies in ICU patients with COVID‐19 pneumonia (COVIDICUS)
Methods	Trial design: quadruple‐masked RCT Sample size: 550 Setting: inpatient Language: French, English Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age ≥ 18 years Admitted to ICU within 48 h Confirmed or highly suspected COVID‐19 infection Acute hypoxaemic respiratory failure (PaO2 < 70 mmHg or SpO2 < 90% on room air or tachypnoea > 30/min or laboured breathing or respiratory distress; need for oxygen flow ≥ 6 L/min) Any treatment intended to treat the SARS‐CoV‐2 infection in the absence of contraindications (either as a compassionate use or in the context of a clinical trial, i.e. remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity) Exclusion criteria Moribund status Pregnancy or breastfeeding Long‐term corticotherapy at a dose of 0.5 mg/kg/d or higher Active and untreated bacterial, fungal or parasitic infection No written informed consent from the patient or a legal representative if appropriate. If absence a legal representative of the patient may be included in emergency procedure Hypersensitivity to dexamethasone or to any of the excipients No affiliation to French social security
Interventions	Details of intervention Dose: dexamethasone 20 mg in 5 mL Route of administration: IV Treatment details of control group (e.g. dose, route of administration): placebo Concomitant therapy: study stratified according to subgroups (only oxygen therapy, CPAP, HFNC, IMV)
Outcomes	Primary study outcome Time to death from all causes (time frame: day 60) Time to need for mechanical ventilation (time frame: day 28) Time to death from all causes within the first 60 days after randomisation
Starting date	10 April 2020
Contact information	Jean François TIMSIT, Pr
Notes	Recruitment status: active, not recruiting Prospective completion date: 31 December 2021 Date last update was posted: 9 February 2021 Sponsor/funding: Assistance Publique ‐ Hôpitaux de Paris