Efficacy of Addition of Naproxen for COVID-19 Infection / Enacovid Study
Phase 1
- Conditions
- COVID-19 InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001301-23-FR
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 584
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
Exclusion Criteria
• Presence of do-not-resuscitate order
• Pregnancy
• Prisoners
• Naproxen allergy or intolerance
• Severe renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;Secondary Objective: To demonstrate the effect of naproxen treatment to in-hospital mortality, morbidity, virus concentration;Primary end point(s): 30-day mortality all causes;Timepoint(s) of evaluation of this end point: 30 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Number of days alive free of mechanical ventilation during 30 days after randomization<br>•Number of days alive outside during 30 days after randomization<br>•Number of days alive outside hospital 30 days after randomization<br>•Maximal changes in Sofa score in the first 7 days after randomization<br>•Time to negativation of virus titer in the nasopharyngeal aspirate (NPA);Timepoint(s) of evaluation of this end point: 30 days