Could a simple steroid course save lives in severe respiratory infections?
NCT ID NCT07199192
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving a 7-day course of corticosteroids (like prednisolone) to hospitalized adults with severe respiratory infections and low oxygen levels can reduce deaths and the need for breathing machines. About 3,000 participants will be randomly assigned to receive the steroid or standard care without it. The goal is to see if this common anti-inflammatory drug improves survival and recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- corticosteroid (prednisolone 40 mg daily)
- What this could lead to
- If it works, this could confirm a standard steroid treatment to lower death risk and shorten hospital stays for severe respiratory infections.
- What could go wrong
- This is a large Phase 4 trial, but steroids can weaken immune response and may not help—or could even harm—some patients. Results may vary by infection type.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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