Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.

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 tuberculosis, 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

All the information will be published and it will be available in open access.

After the end of the trial.

Contact uicec@imibic.org