Status:
COMPLETED
Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)
Lead Sponsor:
Maria del Rosario Garcia de Vicuña Pinedo
Collaborating Sponsors:
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical mani...
Detailed Description
SARCOVID is an investigator-initiated monocentric randomised proof of concept study that aims to evaluate the efficacy and safety of a single dose of sarilumab, in subcutaneous administration, in hosp...
Eligibility Criteria
Inclusion
- Age\> 18 years
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other validated commercial or public health assay
- Documented interstitial pneumonia requiring admission and at least two of the following:
- Fever ≥ 37.8ºC (tympanic)
- IL-6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or equivalent\> 1 mg / kg) or PCR\> 5mg / dL
- Lymphocytes \<600 mm3
- Ferritin\> 300 mcg / L that doubles in 24 hours
- Ferritin\> 600 mcg / L in the first determination and LDH\> 250 U / L
- D-dimer (\> 1 mg / L)
- Informed verbal or administration consent under urgent conditions, documented in the electronic medical record.
Exclusion
- Patients who require mechanical ventilation at the time of inclusion.
- AST / ALT values \> 5 folds upper normal limit.
- Neutrophil count below 500 cells / mm3
- Platelet count below 50,000 cells / mm3
- Documented sepsis or high suspicion by pathogens other than COVID-19.
- Presence of comorbidities that according to clinical judgment could lead to an unfavorable result.
- Complicated diverticulitis or intestinal perforation.
- Current skin infection (eg, uncontrolled dermopiodermitis).
- Immunosuppressive anti-rejection therapy.
- Pregnancy or lactation.
- Previous treatment with tocilizumab or sarilumab.
- Patients participating in some other clinical trial for SARS-CoV-2 infection.
- Patients with known hypersensitivity or contraindication to sarilumab or excipients.
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04357808
Start Date
April 13 2020
End Date
December 4 2020
Last Update
February 11 2021
Active Locations (1)
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1
Hospital Universitario de la Princesa
Madrid, Spain, 28006