Trial NCT04357860; EUDRACT:2020-001531-27
Publication SARICOR - Merchante N, Antimicrob. Agents C (2021) (published paper)
Dates: 2020-07-13 to 2021-03-05
Funding: Mixed (Consejeria de Salud y Familias, Junta de Andalucia, Spain (COVID-19 Research Program); General Sub-Directorate of Networks and Cooperative Research Centers, Ministry of Science and Innovation, Spanish Network for Research in Infectious Diseases; European Regional Development Fund; Spanish Clinical Research Network; ISCIII-Sub-Directorate General for Research Assessment and Promotion)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Spain
Follow-up duration (days): 28
Inclusion criteria
  • Age ≥18 years
  • Hospitalization due to COVID-19 with SARS-CoV-2 infection confirmed by a positive antigen detection test or a polymerase chain reaction assay
  • Interstitial pneumonia confirmed by the presence of infiltrates on chest radiograph or a computer tomography scan
  • IL-6 levels ≥ 40 pg/mL and/or D-dimer > 1500 ng/mL or ≥ 1000 if progressive increments were documented in at least two determinations after admission
Exclusion criteria
  • Presence of ARDS requiring HFNO or mechanical ventilation at randomization (or expected to be started in the first 24 hours after randomization as deemed by decision of the investigator)
  • Patients in which the decision was made to not progress to mechanical ventilation in the event of clinical deterioration
Interventions
Treatment
Sarilumab 400
400 mg subcutaneously single dose

Sarilumab 200
200 mg subcutaneously single dose
Control
Standard care

Participants
Randomized
participants :
Standard care=39
Sarilumab 400=40
Sarilumab 200=39
Characteristics of participants
N= 118
Mean age : NR
78 males
Severity : Mild: n=0 / Moderate: n=93 / Severe: n=22 Critical: n=0
Number of vaccinated participants: NR
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
Development of ARDS requiring HFNO, NIMV or IMV during the first 28 days after randomization.
Documents
available

Protocol

Yes. In English

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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
Some concerns
General comment In addition to the published article, the REACT meta-analysys and study registry was used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome.