Trial NCT04357808
Publication Garcia-Vicuna R, Front Med, 2022 (published paper)
Dates: 2020-04-13 to 2020-10-30
Funding: Mixed (Sanofi Spain)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Spain Follow-up duration (days): 90 | |
| Inclusion criteria | Age >18, <80 years old attending the emergency room of HUP in need for hospitalization or those in hospital wards; COVID-19 infection documented by a positive RT-PCR test or, in absence of a RT-PCR positive test, case definition of COVID 19 infection/pneumonia as per local protocol and the presence of a positive serologic test (IgM/IgA by ELISA); Documented interstitial pneumonia requiring admission and at least two of the following parameters; 1) Fever ≥ 37.8°C (tympanic); 2) IL-6 in serum ≥ 25 pg/mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg/dL; 3) Lymphocytes <600 cells/mm3; 4) Ferritin> 300 μg/L that doubles in 24 hours; 5) Ferritin> 600 μg/L in the first determination and LDH> 250 U/L; 6) D-dimer (> 1 mg/L); Informed verbal consent or requested under urgent conditions, documented in the electronic medical record |
| Exclusion criteria | Patients who require mechanical ventilation at the time of inclusion; AST / ALT values > 5 folds the ULN.; Absolute neutrophil count below 500 cells/mm3; Absolute platelet count below 50,000 cells/mm3; Superimposed infection by pathogens other than COVID-19; Complicated diverticulitis or intestinal perforation; Immunosuppressive antirejection therapy; Pregnancy or lactation; Previous treatment with TCZ or SAR; Contraindication to SAR or excipients; Comorbidities that can likely lead to an unfavorable result. |
| Interventions | |
| Treatment
Sarilumab 200 mg subcutaneous injection twice daily |
|
| Control
Standard care ( / ) Definition of Standard care: Patients in both arms received drugs, including corticosteroids, or full supportive care according to the best SC updated in the local protocol for COVID-19. Patients in the SC were given the option to receive intravenous TCZ after randomization if they worsened at the investigator’s discretion, as this agent had become the SC in our center when the protocol was designed. Other immunomodulators or investigational drugs in trials were prohibited. | |
| Participants | |
| Randomized 30 participants (n1=20 / n2= 10) | |
| Characteristics of participants N=30 Mean age : NR 20 males Severity : Mild: n=4 / Moderate: n=22/ Severe: n=4 Critical: n=0 | |
| Primary outcome | |
| In the register Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation [Time Frame: 7 days from enrolment]; Duration of hospitalisation (days) [Time Frame: 30 days from enrolment ]; Death [Time Frame: 30 days from enrolment] | |
| In the report 1) Mortality by 30 days; 2) Mean change in functional status at day 7 on a 7-category ordinal scale as recommended by the WHO R&D Blueprint Group; 3) Time to discharge from randomization | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
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| 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, protocol, statistical analysis plan and the 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 were used in data extraction and risk of bias assessment. SARCOVID is an investigator-initiated open-label phase II RCT. There is no change from the trial registration in the intervention and control treatments.
This study was updated on April 25th 2022 with data from the published report. |