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

NCT04325633 | Terminated Phase 3 DMC

• 1 other identifier: APHP200387
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-COV-2; Naproxen; Nonsteroidal anti-inflamatory drug

Outcome Measures

Primary Outcomes (1)

• Mortality all causes at day30

  at day30

Secondary Outcomes (5)

• 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

  during 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)

  during 90 days after randomization

Study Arms (2)

1: Naproxen

EXPERIMENTAL

Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)

Drug: 1: Naproxen; Drug: 2: Standard of care

2: Standard of care

PLACEBO COMPARATOR

Standard of care

Drug: 2: Standard of care

Interventions

1: Naproxen DRUG

Description : Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)

1: Naproxen

2: Standard of care DRUG

Standard of care

1: Naproxen; 2: Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Réanimation médico-chirurgicale, Avicenne Hospital

Bobigny, 93000, France

Location

Urgences, Avicenne Hospital

Bobigny, 93000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frédéric ADNET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: April 24, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

FR (2)