Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

Phase 3RecruitingNCT06528444

Instituto de Investigación Sanitaria y Biomédica de Alicante42 enrolled

Overview

Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo. Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Influenza

Interventions

Grup 1 placeboDRUG

placebo 1 capsule (6 mg) /day for 7 days.

Grup 2 dexametasonaDRUG

dexamethasone 1 capsule (6 mg)/day for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)

Alicante, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Spain

RECRUITING

Outcomes

Primary Outcomes

To compare the percentage of patients hospitalized

To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.

Time frame: 10 days

Secondary Outcomes

The National Early Warning Score

To compare the time, in days, between initiation of treatment and clinical stability according to the NEWS2\<2 scale for 24 hours or until hospital discharge, taking the value of the first of the two events to occur

Time frame: 10 days

Common Terminology Criteria for Adverse Events (CTCAE) scale

To compare the frequency of serious adverse effects between groups (grades 3, 4 and 5 on the CTCAE scale).

Time frame: 10 days

Rate of metabolic impact of dexamethasone

To evaluate the metabolic impact of dexamethasone by comparing the function of occurrence of sustained hyperglycemia level 1 and 2, and episodes of hyperglycemia during and at the end of dexamethasone treatment.

Time frame: 10 days

the average hospital stay

To compare the average hospital stay (expressed in days) according to treatment group.

Time frame: 10 days

Number of pacients in ICU admission

To compare the function of occurrence over time of clinical failure, defined as progression to: need for ICU admission, need for intubation or death.

Central Contacts

Javier Mateo, Biologist

CONTACT

965 mateo_jav@isabial.es

Livia Giner

CONTACT

l.gineroncina@gmail.com

Data from ClinicalTrials.gov

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