Trial NCT04357860, EU-CTR 2020-001531-27
Publication SARICOR, Unpublished, 2021 ( )
Dates: 2020-04-28 to 2021-03-09
Funding: Public/non profit (COVID-19 Research Programme. Ministry of Health and Families, Regional Government of Andalusia.)
Conflict of interest: No
Multicenter / Spain |
Follow-up duration (days): 28
|Inclusion criteria||Age ≥18 years and <75 years.
Hospitalisation with COVID-19 (positive PCR in a respiratory tract simple) in absence of respiratory distress (defined as requiring high-flow nasal oxygen or mechanical ventilation).
Interstitial pneumonia confirmed by chest radiography or CT scan.
IL-6 levels>40 pg/mL. In the absence of IL-6, D-dimer >1500 or >1000 if progressive increments between at least two determinations are documented after admission.
In women of childbearing age, a negative pregnancy test.
Signed informed consent.
|Exclusion criteria||SOFA score >6 points.
Patient who, in the researcher’s opinion, is not subsidiary of invasive mechanical ventilation.
Neutrophil count <2×103/μL.
Platelet count <100×109/L.
ALT or AST levels >5 times the upper limit of normal.
Severe renal failure (CrCl <30 mL/min).
Active bacterial infection.
Active tuberculosis or history of not completing treatment against tuberculosis.
Antecedents of diverticulitis.
Hypersensitivity to sarilumab or its excipients.
Treatment with TNF antagonists.
Treatment with anti-IL6 in the previous 30 days.
Chronic treatment (>1 month*) with corticosteroids at doses>0.5 mg/kg/day of prednisone or equivalent. Topical and inhaled corticosteroids are acceptable.
Concomitant treatment with immunomodulators, including dexamethaxone, 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.
Patients receiving immunomodulatory antibody therapy, including immunoglobulins.
Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than five half-lives of the product under investigation.
Any other condition that, in clinical judgement, prevents the patient’s adherence to the protocol.
200 mg subcutaneous injection once-off OR 400 mg subcutaneous injection once-off
Standard care ( / )
Definition of Standard care: Best available treatment up to 14 days
115 participants (n1=76 / n2= 39)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=115/ Severe: n=0 Critical: n=0
|In the register|
Ventilation requirements [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
Proportion of patients requiring or time (in days) until required:
High flow nasal oxygenation (HFNO)
Non-invasive mechanical ventilation type BiPAP
Non-invasive mechanical ventilation type CPAP
Invasive mechanical ventilation
|In the report|
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||The study is not published yet. Data presented was extracted from study registry and The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499-518. The authors have been contacted in order to obtain the results.|