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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Grup 1 placebo

Intervention Type DRUG

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

dexamethasone

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

Group Type ACTIVE_COMPARATOR

Grup 2 dexametasona

Intervention Type DRUG

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

Interventions

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Grup 1 placebo

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

Intervention Type DRUG

Grup 2 dexametasona

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes