NCT04357808
Trial name or title	Efficacy of subcutaneous sarilumab in hospitalised patients with moderate‐severe COVID‐19 infection (SARCOVID)
Methods	RCT, active‐controlled, open‐label study Date of study: April 2020 Location: Spain Phase 2
Participants	Randomised: 30 participants Inclusion criteria Age > 18 years Laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR or other validated commercial or public health assay Documented interstitial pneumonia requiring admission and at least 2 of the following: fever ≥ 37.8ºC (tympanic); IL‐6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or equivalent > 1 mg / kg) or PCR > 5 mg/dL; lymphocytes < 600 mm3; ferritin > 300 mcg / L that doubles in 24 hours; ferritin > 600 mcg / L in the 1st determination and LDH > 250 U/L; D‐dimer ( > 1 mg / L). Informed verbal or administration consent under urgent conditions, documented in the electronic medical record Exclusion criteria Patients who require mechanical ventilation at the time of inclusion AST / ALT values > 5 folds upper normal limit. Neutrophil count below 500 cells / mm3 Platelet count below 50,000 cells / mm3 Documented sepsis or high suspicion by pathogens other than COVID‐19 Presence of comorbidities that according to clinical judgment could lead to an unfavourable result. Complicated diverticulitis or intestinal perforation Current skin infection (e.g. uncontrolled dermopiodermitis) Immunosuppressive anti‐rejection therapy Pregnancy or lactation Previous treatment with tocilizumab or sarilumab Patients participating in some other clinical trial for SARS‐CoV‐2 infection Patients with known hypersensitivity or contraindication to sarilumab or excipients
Interventions	Intervention: sarilumab (SC, 2 x 200 mg, single dose) Control interventions: standard of care
Outcomes	Primary outcome Mean change in clinical status assessment using the 7‐point ordinal scale (7 and 14 days from enrolment) Mortality (30 days from enrolment) Secondary outcomes Time to invasive mechanical ventilation (30 days from enrolment) Non‐serious adverse events (30 days from enrolment)
Starting date	Study start date: 13 April 2020
Contact information	Fundación de Investigación Biomédica ‐ Hospital Universitario de La Princesa, Rosario Garcia de Vicuña, MD PhD
Notes	Ongoing