NCT04357860
Trial name or title	Clinical trial of sarilumab in adults with COVID‐19
Methods	RCT, active‐controlled, open‐label study Date of study: April 2020 Location: Spain Phase 2
Participants	Randomised: 120 participants Inclusion criteria Age ≥ 18 years and < 75 years Admission for confirmed respiratory symptoms to COVID‐19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation Interstitial pneumonia confirmed by chest radiography or CT IL‐6 levels > 40 pg/mL. In its absence, D‐Dimer (DD) > 1500 or > 1000 may be included if progressive increases are documented Negative pregnancy test in women of childbearing age Signature of informed consent Exclusion criteria SOFA score > 6 points Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation Neutrophil count < 2 x 103 / μL Platelet count < 100 x 103 / μL ALT or AST levels > 5 times the upper limit of normal Severe renal failure (CrCr < 30 mL / min) Active bacterial infectious process Active TB, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis History of intestinal ulcer or diverticulitis History of hypersensitivity reactions to sarilumab or its excipients Treatment with TNF antagonists Previous treatment with anti‐IL6 in the previous 30 days Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable Patients on immunosuppressive treatment for any cause HIV‐infected patients with CD4 < 200 / mm3 Past or current history of autoimmune disease or systemic inflammatory disease Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half‐lives of the investigational product Pregnancy Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
Interventions	Intervention: sarilumab (SC, 200 mg/400 mg, up to 14 days) Control interventions: standard of care
Outcomes	Primary outcome Ventilation requirements (at day 28 or when the participant is discharged) Secondary outcomes Mortality (at day 28 or when the participant is discharged) Negative viral conversion (at day 28 or when the participant is discharged) Time to clinical improvement (at day 28 or when the participant is discharged) Proportion of patients requiring invasive mechanical ventilation (at day 28 or when the participant is discharged) Adverse events
Starting date	Study start date: ‐
Contact information	Hospital Universitario Reina Sofía, Antonio Luque, 0034671596070, uicec@imibic.org
Notes	Ongoing