Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Corticosteroid
Treatment groups
3,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
National Institutes of Health (NIH)
Collaborator
University of Minnesota
Collaborator
Source ClinicalTrials.gov