A Phase 2 interventional study of Sarilumab and Standar of care in Covid-19, sponsored by Maria del Rosario Garcia de Vicuña Pinedo. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Maria del Rosario Garcia de Vicuña Pinedo · Phase 2, Interventional, and Treatment
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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Maria del Rosario Garcia de Vicuña Pinedo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Documented interstitial pneumonia requiring admission and at least two of the following:
Exclusion Criteria:
Sarilumab 200 mg, 2 sc injections in pre-filled syringe or pen, single dose. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed
Drug: Sarilumab
Treatment with drugs or procedures in routine clinical practice
Other: Standar of care
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Also known as: Kevzara, SAR153191
Usual clinical care
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
Incidence of serious and non-serious adverse events.
Number of adverse events and number of patients with adverse events
Time frame: 30 days after enrolment
Discontinuation due to adverse reactions
Number of adverse reactions that requires discontinuation of any drug in the study
Time frame: 30 days after enrolment
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.