Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

NCT ID: NCT07199192

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2028-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Corticosteroid

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Corticosteroid

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. Onset in the last 10 days AND

2. Results in hospitalization AND

3. 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

4. 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).

• Hypoxemia, defined as meeting one or more of the following at the time of eligibility assessment:

1. An oxygen saturation <92% in a patient who does not receive chronic supplemental oxygen OR

2. 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

3. 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew W Semler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Jane O'Halloran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington Univeristy School of Medicine (ID-CRU)

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Rebecca Schoenecker

Role: CONTACT

webe0376@umn.edu

612-624-9644

Facility Contacts

Rebecca Schoenecker

Role: primary

webe0376@umn.edu

612-624-9644

Other Identifiers

STRIVE 003

Identifier Type: -

Identifier Source: org_study_id