Efficacy of Addition of Naproxen in the Treatment of critically ill Patients Hospitalized for COVID-19 Infection / Enacovid Study

INTERVENTION: Pharmaceutical Form: Tablet INN or Proposed INN: NAPROXEN Other descriptive name: NAPROXEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ CONDITION: COVID‐19 Infection Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To demonstrate the superiority of naproxen treatment addition to standard of care compared to standard of care in term of 30‐day mortality Primary end point(s): 30‐day mortality all causes Secondary Objective: To demonstrate the effect of naproxen treatment to in‐hospital mortality, morbidity, virus concentration Timepoint(s) of evaluation of this end point: 30 days SECONDARY OUTCOME: Secondary end point(s): • Number of days alive free of mechanical ventilation during 30 days after randomization ; • Number of days alive outside during 30 days after randomization ; • Number of days alive outside hospital 30 days after randomization ; • Maximal changes in Sofa score in the first 7 days after randomization ; • Time to negativation of virus titer in the nasopharyngeal aspirate (NPA) Timepoint(s) of evaluation of this end point: 30 days INCLUSION CRITERIA: • COVID‐19 infected patient • Age 18 years or older • Presence of pneumonia • PaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to supplementary oxygen administration in order to maintain SpO2 range in [94‐98%] or lung infiltrates > 50% • Medical insurance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 292 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292