Can steroids save lives in severe flu pneumonia? new trial aims to find out
NCT ID NCT07351500
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial will test whether adding low or moderate doses of the corticosteroid methylprednisolone to standard care can lower the death rate in adults with severe influenza pneumonia in the ICU. About 496 participants will be randomly assigned to receive either saline (placebo), low-dose, or moderate-dose methylprednisolone. The main goal is to see if the drug reduces deaths within 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Methylprednisolone (a corticosteroid drug)
- What this could lead to
- If it works, this could provide a clear treatment option to reduce deaths from severe influenza pneumonia.
- What could go wrong
- This is an early-stage trial with only 496 participants, and corticosteroids have previously been linked to higher mortality in some flu studies, so results may not be conclusive or positive.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 496 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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. * Admission to the Intensive Care Unit (ICU). * Meeting the diagnostic criteria for community-acquired pneumonia (CAP). * Meeting at least one of the major diagnostic criteria for severe pneumonia: (i) Requirement for endotracheal intubation and mechanical ventilation; (ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation. -Or simultaneously fulfilling three of the minor criteria: (i) Respiratory rate ≥ 30 breaths/min; (ii) PaO₂/FiO₂ ≤ 250 mmHg; (iii) Multilobar infiltrates; (iv) Altered mental status and/or disorientation; (v) Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L); (vi) Leukopenia (white blood cell count \< 4 × 10⁹/L); (vii) Thrombocytopenia (platelet count \< 100 × 10⁹/L); (viii) Hypothermia (core temperature \< 36 °C); (ix) Hypotension (systolic blood pressure \< 90 mmHg) requiring aggressive fluid resuscitation. * Confirmed influenza virus etiology: at least one positive nucleic acid test (RT-PCR/PCR) or next-generation sequencing (NGS) result for influenza virus in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid). * Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within \< 72 hours. * Signed informed consent. Exclusion Criteria: * Patients receiving vasopressor therapy for septic shock at the time of enrollment. * Terminally ill patients (expected survival \<30 days, e.g., advanced malignancy). * Clinical history suggesting overt aspiration. * Documented active gastrointestinal bleeding. * Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection. * Active viral hepatitis or active herpesvirus infection. * Bone marrow suppression or HIV infection. * Refusal of mechanical ventilation and endotracheal intubation. * Uncontrolled hyperglycemia (diabetic ketoacidosis with blood ketones \>3 mmol/L, or hyperosmolar hyperglycemic state with blood glucose \>33.3 mmol/L and elevated osmolality). * Known allergy to corticosteroids. * Patients requiring anti-inflammatory corticosteroids or replacement hydrocortisone for any reason, or those already receiving prednisone \>15 mg/day (or equivalent dose of another corticosteroid). * Pregnant or breastfeeding women.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.
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