EUCTR2020‐001413‐20‐ES.

Study name	Efficacy and safety of siltuximab vs. corticosteroids in hospitalised patients with COVID‐19 pneumonia
Methods	Trial design: phase 2, randomised, open‐label Sample size: 100 Setting: inpatient Language: Spanish, English Number of centres: single‐centre Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age ≥ 18 years old Hospitalised patient (or documentation of a hospitalisation plan if the patient is in an emergency department) with illness of > 5 days of duration with evidence of pneumonia by chest radiography/CT and meets at least 1 of the following requirements: Non‐critical patient with pneumonia in radiological progression Patient with progressive respiratory failure in the last 24 to 48 h Laboratory‐confirmed SARS‐CoV‐2 infection (by PCR) or other commercialised analysis or public health in any sample collected 4 days before the randomisation or COVID‐19 criteria following the defined diagnostic criteria at that time in the centre Patient with a maximum O2 support of 35% Willing and able to comply with the study‐related procedures/evaluations Women of childbearing potential should have a negative serum pregnancy test before enrolment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomised 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 criteria Patient who, in the investigator's opinion, is unlikely to survive > 48 h after 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 (RAN) < 2000/mm3 AST or ALT > 5 times the ULN Platelets < 50,000/mm3 In active treatment with immunosuppressants or previous prolonged treatment (> 3 months) of oral corticosteroids for a disease not related to COVID‐19 at a dose > 10 mg of prednisone or equivalent per day Known active tuberculosis (TB) or known history of TB uncompleted treatment Patients with active systemic bacterial and/or fungal infections 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 ICU Pregnancy or lactation Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose)
Interventions	Details of intervention: siltuximab Dose: 11 mg/kg Route of administration: intravenous Treatment details of control group (e.g. dose, route of administration): methylprednisolone 250 mg/kg Concomitant therapy: no information
Outcomes	Primary study outcome: proportion of patients requiring ICU admission at any time within the study period (time frame 29 days)
Starting date	No information
Contact information	Felipe García: +349322754002884 Email: fgarcia@clinic.cat
Notes	Recruitment status: temporarily halted Prospective completion date: prospective duration of trial 45 days Date last update was posted: no information Sponsor/funding: Fundació Clínic per a la Recerca Biomèdica