NCT04325633: ENACOVID

Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection

Terminated Phase 3 Last updated 25 February 2021

What this trial tests

Phase 3 trial testing 1: Naproxen in COVID-19 in 30 participants. Terminated before completion.

Timeline

24 April 2020

Primary endpoint
15 December 2020

15 December 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	24 April 2020
Primary completion	15 December 2020
Estimated completion	15 December 2020
Sites	2 locations across France

Drugs / interventions tested

• 1: Naproxen — full drug profile →
• 2: Standard of care — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs
   Tufan A, Avanoğlu Güler A, Matucci-Cerinic M. · · 2020 · cited 270× · PMID 32299202 · DOI 10.3906/sag-2004-168
2. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
3. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
4. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
5. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
   Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
6. FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2020 · cited 105× · PMID 32717568 · DOI 10.1016/j.drup.2020.100719
7. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19.
   Perricone C, Triggianese P, Bartoloni E, Cafaro G, et al · · 2020 · cited 86× · PMID 32317220 · DOI 10.1016/j.jaut.2020.102468
8. Non-steroidal anti-inflammatory drugs, prostaglandins, and COVID-19.
   Robb CT, Goepp M, Rossi AG, Yao C. · · 2020 · cited 68× · PMID 32700336 · DOI 10.1111/bph.15206