Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07199192
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Hypoxemia
  • Severe Acute Respiratory Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Corticosteroid — DRUG
    systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge

Study Details

Multicenter, parallel-group, randomized clinical trial comparing the administration of systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days vs no corticosteroid administration among adults hospitalized with severe acute respiratory infection and hypoxemia.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Corticosteroid Group
    Participants in the corticosteroid group will receive systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge, whichever is sooner. Clinicians will select the systemic corticosteroid medication and the route of administration.
  • No Intervention: Control Group
    Participants in the no corticosteroid group will not receive systemic corticosteroids for 7 days or until hospital discharge, whichever is sooner, unless (i) they meet prespecified criteria for the administration of systemic corticosteroids (e.g., anaphylaxis) or (ii) their clinicians determine that the administration of systemic corticosteroids is required for the optimal care of the participant for other reasons.

Primary Outcome Measure

28-day in-hospital mortality [ Time Frame: Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Rebecca Schoenecker
[email protected]
612-624-9644

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By research site
University of Minnesota· Minneapolis, MN

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