Trial EU-CTR 2020-002037-15
Publication SARTRE, Unpublished, 2021 ( )
Dates: 2020-08-01 to 2021-01-08
Funding: Private (Sanofi Aventis S.A. (drug donation))
Conflict of interest: *
Multicenter / Spain |
Follow-up duration (days): 28
1. Informed consent prior to performing any study procedure. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained whenever possible.
2. Male or female adult patients of at least 18 years of age.
3. The patient is positive for SARS-CoV-2 by real-time PCR or other validated tests
4. The patient is hospitalized for COVID-19 without either mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag and at least one of the following:
-Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.),
-Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air that requires supplemental oxygen.
5. More than 7 days between the onset of symptoms (fever, cough, and/or dyspnea) and treatment administration day. In the absence of fever, cough, or dyspnea, other symptoms like astenia, headache, or gastrointestinal symptoms may be considered.
6. The patient present progressive elevation of inflammatory parameters suggestive of a hyperinflammatory syndrome :
- Presence of elevated IL-6 (>40 pg/mL)
-Elevated d-dimer (>1.0 mcg/ml), or alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 24-48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
7. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
8. Negative pregnancy test in case of fertile women
|Exclusion criteria||1. Patients with high oxygen requirements including face mask with reservoir, non-invasive
mechanical ventilation or high flow nasal cannula, or mechanical ventilation.
2. Patients admitted at the ICU
3. Participation in any other clinical trial of an experimental treatment for COVID-19.
4. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
5. Any hypersensitivity or allergy to the administration of sarilumab or corticosteroids.
6. Current treatment with immunosuppressive or any immunomodulatory medication within 8 weeks of baseline.
7. Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin
8. AST/ALT values > 10 x ULN
9. Neutropenia (< 0.5 x 109/L).
10. Severe thrombocytopenia (< 50 x 109/L).
11. Sepsis caused by an alternative pathogen.
12. Diverticulitis with risk of perforation.
13. Ongoing infectious dermatitis.
14. Patients with another active infection, including localized infections.
15. Pregnant or breast-feeding females will be excluded
200 mg IV infusion for 1 hour (if body weight < 75 kg)
400 mg IV infusion for 1 hour (if body weight >= 75 kg)
Standard care ( / )
Definition of Standard care: *
140 participants (n1=70 / n2= 70)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0
|In the register|
Proportion of patients progressing to severe respiratory failure (Brescia-COVID Scale ≥2), ICU admission, or death.
|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.|