Not Yet RecruitingPhase 4

Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

United States3,000 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Onset in the last 10 days AND
✓. Results in hospitalization AND
✓. At least one symptom or sign of respiratory illness (defined as purulent sputum, new or worsened cough, new or worsened dyspnea, tachypnea with respiratory rate ≥22 breaths per minute, rales, or bronchial breath sounds) AND
✓. At least one symptom or sign of acute infection (defined as a temperature ≥38°C or ≤36°C, feverishness, chills, altered mental status, a white blood cell count of \>12,000/mm3, \<4,000/mm3, or \>10% immature neutrophils, or imaging findings consistent with acute respiratory infection).
✓. An oxygen saturation \<92% in a patient who does not receive chronic supplemental oxygen OR
✓. Receipt of ≥3 liters per minute of supplemental oxygen or a fraction of inspired oxygen of ≥0.35 in a patient who does not receive chronic supplemental oxygen OR
✓. Receipt of a flow rate of supplemental oxygen ≥3 liters per minute greater than pre-illness baseline or a fraction of inspired oxygen ≥0.10 greater than pre-illness baseline in a patient who receives chronic supplemental oxygen.

What they're measuring

28-day in-hospital mortality

Timeframe: Day 28

Advanced respiratory support

Timeframe: Day 28

Duration of advanced respiratory support

Timeframe: Day 28

Duration of hospitalization

Timeframe: Day 28

Trial details

NCT IDNCT07199192

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-12-01

Contact for this trial

Rebecca Schoenecker

612-624-9644 webe0376@umn.edu

View on ClinicalTrials.gov More Hypoxemia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Onset in the last 10 days AND
✓. Results in hospitalization AND
✓. At least one symptom or sign of respiratory illness (defined as purulent sputum, new or worsened cough, new or worsened dyspnea, tachypnea with respiratory rate ≥22 breaths per minute, rales, or bronchial breath sounds) AND
✓. At least one symptom or sign of acute infection (defined as a temperature ≥38°C or ≤36°C, feverishness, chills, altered mental status, a white blood cell count of \>12,000/mm3, \<4,000/mm3, or \>10% immature neutrophils, or imaging findings consistent with acute respiratory infection).
✓. An oxygen saturation \<92% in a patient who does not receive chronic supplemental oxygen OR
✓. Receipt of ≥3 liters per minute of supplemental oxygen or a fraction of inspired oxygen of ≥0.35 in a patient who does not receive chronic supplemental oxygen OR
✓. Receipt of a flow rate of supplemental oxygen ≥3 liters per minute greater than pre-illness baseline or a fraction of inspired oxygen ≥0.10 greater than pre-illness baseline in a patient who receives chronic supplemental oxygen.