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Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial

ConditionsHypoxemiaSevere Acute Respiratory Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Corticosteroid

    Drug

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

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Corticosteroid GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

28-day in-hospital mortality

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.

Time frame
Day 28
2

Advanced respiratory support

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.

Time frame
Day 28
3

Duration of advanced respiratory support

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.

Time frame
Day 28
4

Duration of hospitalization

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

Time frame
Day 28

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

National Institutes of Health (NIH)

Collaborator

University of Minnesota

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: