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STAR Trial: Steroid Treatment for Severe Acute Respiratory Infection

The STAR (Steroid Treatment for Severe Acute Respiratory Infection) trial is studying if a corticosteroid drug, given as 40 mg of prednisolone per day for 7 days, can help adults hospitalized with severe acute respiratory infection (SARI) and hypoxemia (low oxygen in the blood). SARI means you have a suspected respiratory infection that started within the last 10 days, led to hospitalization, and includes breathing problems. The study aims to enroll 3000 participants and will compare those who receive prednisolone to those who do not. Researchers will measure how many people die in the hospital within 28 days, if they need advanced breathing support, and for how long. The current recruitment status is unclear.

Study design
This is a multicenter, randomized clinical trial comparing two groups of participants. It plans to enroll 3000 adults.
What's involved
Participants would receive systemic corticosteroids (prednisolone) for 7 days or until discharge, or no corticosteroids.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants to measure outcomes up to 28 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07199192

Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~3,000 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Corticosteroid

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
28-day in-hospital mortality
Measured over Day 28
+3 more outcomes measured

Conditions

Hypoxemia
Severe Acute Respiratory Syndrome

Explore related trials

HypoxemiaSevere Acute Respiratory Infection

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Matthew W Semler, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • Jane O'Halloran, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington Univeristy School of Medicine (ID-CRU)

Who to contact

Rebecca Schoenecker
[email protected]
612-624-9644
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years.
Severe acute respiratory infection (SARI), defined as a suspected infection of the respiratory tract that meets each of the following 4 criteria:
Hypoxemia, defined as meeting one or more of the following at the time of eligibility assessment:

Exclusion

Hospitalized for \>72 hours
Primary etiology of hypoxemia is a condition other than respiratory infection
Known allergy or adverse reaction to systemic corticosteroids
Known active infection with SARS-CoV-2, known active infection with Pneumocystis jirovecii, or another established indication for systemic corticosteroids
Known active disseminated or pulmonary infection with Mycobacterium tuberculosis, Aspergillus, Blastomyces, Coccidioides, Cryptococcus, Histoplasma, or Strongyloides species; active systemic infection with herpes simplex virus, varicella zoster virus, or cytomegalovirus; or another established contraindication to systemic corticosteroids
Prisoner
Treatment is prioritizing end-of-life symptom management over prolongation of life
Investigator determines that participation in the trial is not in the patient's best interest
Receipt of greater than 14 days of systemic corticosteroids at a dose equivalent to greater than 10 mg of prednisolone per day in the 30 days prior to hospital presentation (i.e., chronic corticosteroids)
Receipt of systemic corticosteroids at a dose equivalent to greater than 30 mg of prednisolone per day on 2 or more calendar days since hospital presentation
Clinicians determine that the administration of systemic corticosteroids at a dose equivalent to greater than 10 mg of prednisolone per day is required, or is likely to be required in the next 24 hours, for the optimal care of the patient (such as for acute exacerbation of chronic obstructive pulmonary disease, adrenal insufficiency, asthma, continuation of chronic corticosteroid therapy, or severe shock)
Clinicians determine that the administration of systemic corticosteroids is not consistent with the optimal care of the patient (such as for recent peptic ulcer disease, recent gastrointestinal bleeding, severe burns, severe delirium, severe hyperglycemia or diabetic ketoacidosis, or severe hypertension)
Patient (or surrogate decision-maker / legally authorized representative) declines to provide informed consent to participate

What this trial measures

  • 28-day in-hospital mortalityDay 28

    defined as death from any cause between randomization (Day 0) and 28 days (the end of Study Day 27. Outcome ascertainment ends at hospital discharge.

  • Advanced respiratory supportDay 28

    receipt of extracorporeal membrane oxygenation (ECMO), IMV, noninvasive mechanical ventilation, or high-flow nasal cannula (HFNC) at a rate of ≥30 liters per minute and a fraction of inspired oxygen of ≥0.4. Mechanical ventilation received solely to facilitate the performance of a procedure (e.g., mechanical ventilation for general endotracheal anesthesia limited to the performance of a surgery) will not qualify. Noninvasive mechanical ventilation received solely for the treatment of obstructive sleep apnea or obesity hypoventilation syndrome will not qualify.

  • Duration of advanced respiratory supportDay 28

    calculated as a count of calendar days, beginning with the Study Day on which the participant first received advanced respiratory support and ending with the Study Day on which the participant last received advanced respiratory support during the outcome window. Outcome ascertainment ends at hospital discharge.

  • Duration of hospitalizationDay 28

    calculated as the number of calendar days on which the participant is physically located in a short-term acute care hospital beginning at the time of randomization (Day 0) and ending with the Study Day on which the participant was discharged from the hospital during the outcome window