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

Sponsor
Instituto de Investigación Sanitaria y Biomédica de Alicante
Study ID
NCT06528444
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Grup 1 placebo — DRUG
    placebo 1 capsule (6 mg) /day for 7 days.
  • Grup 2 dexametasona — DRUG
    dexamethasone 1 capsule (6 mg)/day for 7 days

Study Details

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.

Key Dates

First listed
Jul 30, 2024
Start date
Oct 1, 2024
Status verified
Feb 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    placebo 1 capsule (6 mg) /day for 7 days.
  • Active Comparator: dexamethasone
    dexamethasone 1 capsule (6 mg)/day for 7 days

Primary Outcome Measure

To compare the percentage of patients hospitalized [ Time Frame: 10 days ]

Central Contacts

Related Studies