Can one infusion speed recovery from sickle cell lung crisis?
NCT ID NCT06818266
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a single dose of tocilizumab, an anti-inflammatory drug, can help children and adults with sickle cell disease recover faster from acute chest syndrome—a serious lung condition. Participants receive either the drug or a placebo, and researchers measure how quickly they can stop needing oxygen or breathing support. The trial aims to enroll 130 people aged 2 and older.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tocilizumab (a drug that reduces inflammation)
- What this could lead to
- If it works, this could provide a new treatment to help sickle cell patients recover faster from acute chest syndrome, a serious lung complication.
- What could go wrong
- This is a Phase 3 trial, but it is still early to know if tocilizumab will work better than standard care. There are risks like infections or allergic reactions from the drug.
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 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jul 2027
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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2 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. SCD patient of all genotypes (SS, SC, S/β0 and S/β+ or other major SCD syndrome) 2. Age ≥ 2 years old 3. Hospitalized for ACS, defined by the WHO as the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging, (X-ray, lung ultrasound, or CT scan) 4. Requiring supplemental oxygen ≥ 2 L/min for SpO2 ≥ 95% or non-invasive respiratory support (high flow nasal oxygen or continuous positive airway pressure or bilevel non-invasive ventilation) or invasive mechanical ventilation or ECMO, for less than 48 hours 5. Negative pregnancy test for girls or women of childbearing age 6. Freely given, informed and written consent of patient or legal representatives 7. Affiliation to the social security (or health insurance) 8. Effective contraception up to 3 months after the administration of treatment (tocilizumab or placebo) Exclusion Criteria: 1. Impossibility to perform tocilizumab/placebo injection within the first 48 hours of supplemental oxygen ≥2L/min for SpO2≥95% and/or respiratory support (as defined in inclusion criteria n°4). If exchange transfusion is indicated at inclusion, it has to be performed before the injection of tocilizumab/placebo. 2. Known hypersensitivity to tocilizumab or its excipients 3. Known active current severe bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster) 4. Immunization with a live/attenuated vaccine within the last 4 weeks 5. Immunomodulatory therapy, anti-rejection therapy, cell depleting therapies and investigational agents within the last 3 months 6. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 7. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions that might predispose a patient to perforations 8. Evidence of malignant disease or malignancies diagnosed within the last 3 years 9. Pregnancy or breastfeeding 10. Imminent and inevitable progression towards death in the opinion of the investigator 11. Absolute neutrophil count \< 1.0 G/L or platelets \< 50 G/L 12. ALT or AST \> 5-fold the upper limit of normal 13. Glomerular Filtration rate (GFR) \< 60 mL/min/1,73 m² 14. Current enrolment in another interventional research concerning a medicinal product for human use
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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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Department of General Pediatrics and Sickle Cell Center, Necker-Enfants malades Hospital
RECRUITINGParis, 75015, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
- Tiny biochip could reveal sickle cell severity
- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?
- Can a softer transplant cure sickle cell disease?