Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

NCT07199192 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Hypoxemia
  • Severe Acute Respiratory Syndrome

Interventions

DRUG

Corticosteroid

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • University of Minnesota

    collaborator OTHER
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew W Semler, MD · Vanderbilt University Medical Center

  • Jane O'Halloran, MD, PhD · Washington Univeristy School of Medicine (ID-CRU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199192 on ClinicalTrials.gov