Can a Blood-Cleansing combo tame deadly lung Flare-Ups?
NCT ID NCT03584802
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether a combination of plasma exchange, rituximab, and intravenous immunoglobulins can improve survival in people hospitalized in intensive care with a severe acute exacerbation of idiopathic pulmonary fibrosis (IPF). IPF is a progressive lung disease, and these flare-ups are often fatal. The treatment aims to remove and block harmful antibodies that may attack the lungs. The study will compare this approach against standard care to see if it reduces deaths within 28 days and over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of therapeutic plasma exchange, rituximab, and intravenous immunoglobulins, given alongside corticosteroids.
- What this could lead to
- If successful, this combination could offer a new way to improve survival during the most dangerous flare-ups of idiopathic pulmonary fibrosis.
- What could go wrong
- This is a very small early trial, and the treatment is intensive with potential side effects. It is not yet known if it will work better than standard care.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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5 people
The number who actually took part.
- Started
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May 2019
- Finished
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Nov 2019
- 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: 1. Patient ≥ 18 years of age 2. Admitted to ICU in the last 72 h 3. Definite or probable IPF diagnosis defined on 2018 ATS/ERS/JRS/ALAT guidelines or a possible usual interstitial pneumonia pattern on HRCT without etiology. 4. Definite AE-IPF according to the 2018 revised criteria : 1. Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and or histopathologic changes consistent with usual interstitial pneumonia (UIP) pattern on the current evaluation); 2. Acute worsening or development of dyspnea typically of less than one-month duration; 3. Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with a UIP pattern (if no previous computed tomography is available, the qualifier "new" can be dropped); 4. Deterioration not fully explained by cardiac failure or fluid overload. 5. PaO2/FiO2 ratio \< 200 measured on FiO2 1 Exclusion Criteria: 1. Known hypersensitivity intravenous immunoglobulins or rituximab 2. Severe heart failure 3. Active and uncontrolled bacterial fungal or parasitic infection ruled out by at least one of these two conditions 1. Procalcitonin value at inclusion \< 0.25 ng/mL OR 2. Adapted antimicrobial therapy for at least 48 hours at inclusion 4. Positive multiplex PCR for Influenzae A and B, or VRS 5. Deep Veinous Thrombosis or Pulmonary embolism in the last six months 6. Prior exposures to human-murine chimeric antibodies 7. Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.) 8. Subject treated with more than 2 boluses of methylprednisolone (total dose \> 500mg of methylprednisolone) or one dose \> 10mg/kg in the last 72 hours 9. Uncorrectable coagulopathies or thrombocytopenia \< 30000/mm3 10. Active cancer (other than basal cell carcinoma of the skin) 11. Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia) 12. Pregnancy 13. Patient listed for lung transplantation 14. Patient on ECMO 15. Patient with a do-not-intubate order at inclusion 16. Concurrent participation in other experimental trials 17. Not Affiliation to the French social security 18. Not Written informed consent from the patient or a legal representative if appropriate 19. Hypersensitivity to corticosteroids, cotrimoxazole / atovaquone 20. Patients with severe renal insufficiency (creatine clearance \<15ml / min)
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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.
Contacts and locations
Locations
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Hôpital Bichat Claude Bernard
Paris, 75018, France