EUCTR2020‐002037‐15‐ES
Trial name or title	Multicenter, randomized, open‐label study to evaluate the efficacy and safety of SOC + sarilumab versus standard of care for the early treatment of COVID‐19‐pneumonia in hospitalized patients
Methods	RCT, active‐controlled, open‐label study Date of study: May 2020 Location: Spain Phase 2
Participants	Randomised: 200 participants Inclusion criteria Patients willing to provide written informed consent to participate in this study. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible. The patient is at least 18 years of age. The patient is positive for novel coronavirus by real‐time RT‐PCR The patient is hospitalised for COVID‐19 without either mechanical ventilation (invasive or non‐invasive) or oxygen mask with reservoir bag and at least 1 of the following: radiographic evidence of pulmonary infiltrates by imaging (chest x‐ray, CT scan, etc.); OR clinical assessment (evidence of rales/crackles on exam); AND SpO2 ≤ 94% on room air that requires supplemental oxygen. More than 7 days between the onset of symptoms (fever, dyspnoea, and/or cough) and treatment administration day. In the absence of fever, cough, or dyspnoea, other symptoms like asthenia, headache, or gastrointestinal symptoms may be considered The patients present progressive elevation of inflammatory parameters suggestive of a hyperinflammatory syndrome: presence of elevated IL‐6 (> 40 pg/mL); OR elevated D‐dimer (> 1.0 mcg/mL), or alternatively, progressive worsening in at least 2 of these inflammatory parameters in the prior 48 hours: CRP, LDH, serum ferritin, lymphopenia, or D‐dimer Exclusion criteria Requiring mechanical ventilation (invasive or non‐invasive) or oxygen mask with reservoir bag at screening Participation in any other clinical trial of an experimental treatment for COVID‐19 In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments Any incompatibility or allergy to the administration of sarilumab or corticosteroids
Interventions	Intervention: sarilumab (IV, 200 mg) Control interventions: standard of care
Outcomes	Primary outcome Progression to severe respiratory failure (from baseline up to day‐15) ICU admission (from baseline up to day‐15) Mortality (from baseline up to day‐15) Secondary outcomes Time to progression to severe respiratory failure
Starting date	Study start date: 25 May 2020
Contact information	Hospital Universitario Puerta de Hierro Majadahonda, 0034911917479, mariabelen.ruiz@salud.madrid.org
Notes	Ongoing