Can matching drugs to biology beat ARDS?
NCT ID NCT07779642
First seen Aug 21, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This trial tests whether two existing drugs, simvastatin and baricitinib, can help people with acute respiratory distress syndrome (ARDS), a severe lung condition that causes breathing failure. Participants are grouped by biological markers into subtypes, then randomly assigned to one of the drugs or usual care. The goal is to see if matching treatment to a patient's specific biology improves outcomes, such as days alive and free from organ support.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simvastatin and baricitinib, two drugs given by mouth or feeding tube, compared with usual care.
- What this could lead to
- If successful, this could lead to more personalized treatments for ARDS, improving survival and reducing time on life support.
- What could go wrong
- This is an early-stage trial, and the drugs may not work for all subtypes or could cause side effects. Results are uncertain and need confirmation.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
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: Critically ill patients in hospital and at least 1 of the following: 1. Acute respiratory distress syndrome (ARDS). ARDS as defined by: 1. a known acute clinical insult or new or worsening respiratory dysfunction 2. receiving respiratory support via invasive mechanical ventilation or non- invasive mechanical ventilation including continuous positive airway pressure, or high flow nasal oxygen greater than or equal to 30L/min 3. within the same 24-hour time period: i. bilateral opacities on chest imaging not fully explained by effusion, lobar/lung collapse/atelectasis, or nodules ii. respiratory failure not fully explained by cardiac failure, fluid overload, pulmonary embolism, acute airway disease iii. Pa02/Fi02 ration \<40 kPa from arterial blood gases, or Sp02 \<315 from pulse oximetry where Sp02 \<97 2. A pandemic associated syndrome Exclusion criteria: Simvastatin: 1. More than 48 hours from the diagnosis of AHRF 2. Patient is known to be pregnant 3. Liver transaminases \>8 times the upper limit of the normal range 4. Creatine kinase \>10 times the upper limit of the normal range 5. Currently receiving ongoing treatment with any of the following: itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil, or diltiazem. 6. Severe renal impairment (eGFR \< 30mL/min and not receiving renal replacement therapy). 7. Current or recent treatment (within 2 weeks) with statins 8. Physician decision that a statin is required for proven indication 9. Contraindication to enteral drug administration, e.g., patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded. 10. Known hypersensitivity to simvastatin Baricitinib 1. More than 48 hours from the diagnosis of AHRF 2. Patient is known to be pregnant 3. Liver transaminases \>8 times the upper limit of the normal range 4. Absolute neutrophil count less than 0.5x10 9/L 5. Currently receiving ongoing immunosuppressants (high dose corticosteroids, B and T cell targeted therapies, interferon, or JAK inhibitors) 6. Severe renal impairment (eGFR \< 15mL/min) or receiving renal replacement therapy 7. Known active tuberculosis infection or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines. 8. Contraindication to enteral drug administration, e.g., patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded. 9. Known hypersensitivity to baricitinib
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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
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smarter ventilator setting spare damaged lungs on ECMO?
- Can varying breath size protect lungs on a ventilator?
- Immune cell infusion aims to free ARDS patients from ventilators
- New ventilation strategy aims to reduce lung damage in severe pneumonia
- Scientists build a biobank to decode ARDS and personalize treatment