HypoxemiaPhase 4STARNCT07199192
Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial
A Phase 4 study testing Corticosteroid in people with Hypoxemia and Severe Acute Respiratory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Severe Acute Respiratory Syndrome
- What is being tested?
- Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
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- Hypoxemia, defined as meeting one or more of the following at the time of eligibility assessment:
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Rebecca Schoenecker, 612-624-9644, webe0376@umn.edu
About this study
Official title: A Multicenter, Randomized, Controlled Trial to Evaluate the Effectiveness and Safety of Systemic Corticosteroid Treatment for Hospitalized Patients With Severe Acute Respiratory Infection and Hypoxemia (STRIVE 003)
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
- Being tested
- Corticosteroid
- Medical subject headings
- Hypoxia, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
systemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Group | Experimental | 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. Receives: Drug: Corticosteroid |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
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.
Measured: Day 28
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.
Measured: Day 28
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
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Matthew W Semler, MD, Principal investigator, Vanderbilt University Medical CenterJane O'Halloran, MD, PhD, Principal investigator, Washington Univeristy School of Medicine (ID-CRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199192
- Sponsor's protocol ID
- STRIVE 003
- Acronym
- STAR
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial to Evaluate the Effectiveness and Safety of Systemic Corticosteroid Treatment for Hospitalized Patients With Severe Acute Respiratory Infection and Hypoxemia (STRIVE 003)
- ClinicalTrials.gov ID
- NCT07199192
- Acronym / sponsor ID
- STAR / STRIVE 003
- Conditions
- Hypoxemia, Severe Acute Respiratory Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), University of Minnesota
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Group | Experimental | Drug: CorticosteroidParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroidsystemic corticosteroids at a dose equivalent to 40 mg of prednisolone per day for 7 days or until discharge | Drug | Corticosteroid Group |
Primary outcome
28-day in-hospital mortality
Time frame: Day 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 support
Time frame: Day 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 support
Time frame: Day 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 hospitalization
Time frame: Day 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew W Semler, MD principal investigator
Vanderbilt University Medical Center
Jane O'Halloran, MD, PhD principal investigator
Washington Univeristy School of Medicine (ID-CRU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid in people with Hypoxemia and Severe Acute Respiratory Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Schoenecker (612-624-9644, webe0376@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day in-hospital mortality (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.