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Publication SARICOR, Unpublished, 2021 ( )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
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
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. Pregnancy. Any other condition that, in clinical judgement, prevents the patient’s adherence to the protocol. |
| Interventions | |
| Treatment
Sarilumab 200 mg subcutaneous injection once-off OR 400 mg subcutaneous injection once-off |
|
| Control
Standard care ( / ) Definition of Standard care: Best available treatment up to 14 days | |
| Participants | |
| Randomized 115 participants (n1=76 / n2= 39) | |
| Characteristics of participants N=115 Mean age : NR 78 males Severity : Mild: n=0 / Moderate: n=115/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| 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 NR | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
| 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. |