Efficacy of Addition of Naproxen for COVID-19 Infection / Enacovid Study

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001301-23-FR

Enrollment

584

Registered

2020-03-26

Start date

2020-04-10

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Infection

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: NAPROXEN Other descriptive name: NAPROXEN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • COVID-19 infected patient • Age 18 years or older • Presence of pneumonia • PaO2/FiO2 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

Exclusion criteria: • Presence of do-not-resuscitate order • Pregnancy • Prisoners • Naproxen allergy or intolerance • Severe renal failure

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France

Contacts

Public ContactEldoie SOLER

Assistance Publique - Hôpitaux de Paris

elodie.soler@aphp.fr+3301 44 84 17 35

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026