Evaluating dexamethasone for severe influenza

Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

This study is testing whether the medication dexamethasone can help hospitalized patients with severe influenza recover better than those who receive a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante (Research network)
• Drugs / interventions: prednisone
• Locations: 2 sites (Alicante and 1 other locations)
• Trial ID: NCT06528444 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, multicenter phase III evaluation of dexamethasone's efficacy and safety compared to a placebo in patients diagnosed with severe influenza. Participants must be hospitalized and have a confirmed diagnosis of influenza A or B virus infection. The study aims to determine whether dexamethasone can improve patient outcomes in this population. The trial will involve administering either dexamethasone or a placebo to eligible patients and monitoring their recovery.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized adults aged 18 years and older with a confirmed diagnosis of severe influenza.

Not a fit: Patients with bronchial hyperresponsiveness requiring systemic corticosteroids or those on ECMO may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from severe influenza.

How similar studies have performed: Other studies have explored corticosteroids in viral infections, but the specific use of dexamethasone for severe influenza is less established, making this approach somewhat novel.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥ 18 years.
2. Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
3. Hospitalized patients with an estimated hospital stay of more than 24 hours.
4. In previous treatment or concomitant start of treatment with oseltamivir.
5. For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
6. Signed informed consent.

Exclusion Criteria:

* 1\. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.

  2\. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).

  3\. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.

  6\. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.

  7\. Patients co-infected with SARS-CoV-2 or RSV.

Where this trial is running

Alicante and 1 other locations

• Hospital General Universitario Dr. Balmis de Alicante (centro coordinador) — Alicante, Spain (Recruiting)
• Hospital General Universitario de Elche — Elche, Spain (Recruiting)

Study contacts

• Study coordinator: Javier Mateo, Biologist

Conditions Influenza