Covid-19 Living Data

Trial EU-CTR 2020-002037-15
Publication SARTRE - Sancho-Lopez A, Infect Dis Ther (2021) (published paper)
Dates: 2020-08-04 to 2021-03-23
Funding: Private (Biomedical Research Foundation of the Puerta de Hierro Majadahonda University Hospital; Sanofi (drug donation))
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Spain Follow-up duration (days): 28
Inclusion criteria	Patients at least 18 years of age and hospitalized due to COVID-19 confirmed by positive RT-PCR or antigen test Presented with pneumonia defined by the radiographic evidence of pulmonary infiltrates by imaging, or rales/crackles on examination, and required standard oxygen supplement due to SpO2 ≤ 94% on room air Time from symptom onset to inclusion must be at least 7 days Patients must present elevation of IL-6 more than 40 pg/mL, or d-dimer more than 1.0 mcg/ml, or at least two of the following analytical inflammatory parameters: elevated C-reactive protein (CRP), lactate dehydrogenase (LDH), serum ferritin, or lymphopenia.
Exclusion criteria	Patients with high oxygen requirements (including face mask with reservoir bag, non-invasive mechanical ventilation or high flow nasal cannula, or mechanical ventilation) Had been on treatment with CS for more than 1 day Were admitted to the intensive care unit (ICU) Pregnant or lactating Had allergy or hypersensitivity to sarilumab or CS Had received immunosuppressive monoclonal antibody therapy within the past 5 months AST/ALT values more than 10 x ULN Neutropenia (less than 0.5 x 109/L) Severe thrombocytopenia (less than 50 x 109/L) Sepsis caused by an alternative pathogen Diverticulitis with risk of perforation Ongoing infectious dermatitis.
Interventions
	Treatment Sarilumab 200 mg IV infusion single dose for 1 hour (if body weight < 75 kg); 400 mg IV infusion for 1 hour (if body weight >= 75 kg)
	Control Standard care
Participants
	Randomized participants : Sarilumab=99 Standard care=102
	Characteristics of participants N= 201 Mean age : NR 141 males Severity : Mild: n=0 / Moderate: n=201 / Severe: n=0 Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register Proportion of patients progressing to severe respiratory failure (Brescia-COVID Scale ≥2), ICU admission, or death.
	In the report Proportion of patients progressing to severe respiratory failure (Brescia-COVID equal or higher than 3, defined by the need of high frequency nasal ventilation, CPAP or noninvasive ventilation or mechanical ventilation), admission to the ICU, or death.
Documents available	Protocol Yes. In English Statistical plan Yes 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 study registry and supplementary file were used in data extraction and risk of bias assessment. 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 was also available. The registry primary outcome does not reflect the reported primary outcome. Outcomes from the registry were specified at 15 days as a timepoint vs the outcomes in report are reported at 28 days as a timepoint. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. This study was updated on November 18th, 2021 with data from the published journal report. This study was updated on August 4th, 2022 with data extracted after contact with authors.