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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Usual clinical care
Hospital Universitario de la Princesa
Madrid, Spain
Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation
Score ranges 1-7 1. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized
Time frame: 7 days from enrolment
Duration of hospitalisation (days)
Days from the date of enrolment to the date of discharge
Time frame: 30 days from enrolment
Death
Number of deaths
Time frame: 30 days from enrolment
Time to become afebrile (days)
Time to become afebrile for a minimum period of 48 hours, without antipyretics
Time frame: 30 days from enrolment
Time to non-invasive mechanical ventilation (days)
Days from enrolment to non-invasive mechanical ventilation
Time frame: 30 days from enrolment
Time to invasive mechanical ventilation (days)
Days from enrolment to invasive mechanical ventilation
Time frame: 30 days from enrolment
Time to independence from supplementary oxygen therapy (days)
Days from enrolment to supplementary oxygen therapy withdrawal
Time frame: 30 days from enrolment
Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation
Scale ranges 1-7: 1. Death 2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles. 4. Hospitalized with oxygen supplement 5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID) 6. Hospitalized, without oxygen supplement and without the need for continued medical care 7. Not hospitalized
Time frame: 14 days from enrolment
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