The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.
SARCOVID is an investigator-initiated monocentric randomised proof of concept study that aims
to evaluate the efficacy and safety of a single dose of sarilumab, in subcutaneous
administration, in hospitalised patients with moderate to early severe COVID-19 infection,
compared to the current standard of care.
Drug: Sarilumab
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Other Name: Array
Other: Standar of care
Usual clinical care
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 two of the
following:
1. Fever ≥ 37.8ºC (tympanic)
2. IL-6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or
equivalent> 1 mg / kg) or PCR> 5mg / dL
3. Lymphocytes <600 mm3
4. Ferritin> 300 mcg / L that doubles in 24 hours
5. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
6. 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
unfavorable result.
- Complicated diverticulitis or intestinal perforation.
- Current skin infection (eg, 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.
Hospital Universitario de la Princesa
Madrid, Spain
Rosario Garcia de Vicuña, MD PhD, Principal Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa