Status:
COMPLETED
Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia
Lead Sponsor:
Judit Pich Martínez
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disea...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Hospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:
- Non-critical patient with pneumonia in radiological progression and / or
- Patient with progressive respiratory failure
- Laboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.
- Be willing and able to comply with the study related procedures / evaluations.
- Women of childbearing potential \* should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).
- Written informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.
- When circumstances so allow, participants should sign the consent form. The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.
Exclusion
- Patient who, in the investigator's opinion, is unlikely to survive\> 48 hours after the inclusion in the study.
- Presence of any of the following abnormal analytical values at the time of the inclusion in the study:
- absolute neutrophil count less than 2000 / mm3;
- AST or ALT\> 5 times the upper limit of normality;
- platelets \<50,000 per mm3.
- Patients with respiratory support greater than or equal to 60%
- In active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.
- Known active tuberculosis or known history of tuberculosis uncompleted treatment.
- Patients with active systemic bacterial and / or fungal infections.
- Patients who have received previous treatment with IL6 inhibitor (tocilizumab, sarilumab).
- Participants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.
- Patients who do not have entry criteria in the Intensive Care Unit.
- Pregnancy or lactation.
- Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT04329650
Start Date
April 15 2020
End Date
February 26 2021
Last Update
September 21 2023
Active Locations (4)
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1
Hospital Germans Trias i Pujol
Badalona, Spain
2
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
3
Hospital Universitario de Salamanca
Salamanca, Spain
4
Hospital Universitari Mútua de Terrassa
Terrassa, Spain