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Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) (SARCOVID)

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ClinicalTrials.gov Identifier: NCT04357808
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Information provided by (Responsible Party):
Maria del Rosario Garcia de Vicuña Pinedo, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Tracking Information
First Submitted Date  ICMJE April 14, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date February 11, 2021
Actual Study Start Date  ICMJE April 13, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation [ Time Frame: 7 days from enrolment ]
    Score ranges 1-7
    1. Death;
    2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    7. Not hospitalized
  • Duration of hospitalisation (days) [ Time Frame: 30 days from enrolment ]
    Days from the date of enrolment to the date of discharge
  • Death [ Time Frame: 30 days from enrolment ]
    Number of deaths
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Time to become afebrile (days) [ Time Frame: 30 days from enrolment ]
    Time to become afebrile for a minimum period of 48 hours, without antipyretics
  • Time to non-invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to non-invasive mechanical ventilation
  • Time to invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to invasive mechanical ventilation
  • Time to independence from supplementary oxygen therapy (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to supplementary oxygen therapy withdrawal
  • Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation [ Time Frame: 14 days from enrolment ]
    Scale ranges 1-7:
    1. Death
    2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
    4. Hospitalized with oxygen supplement
    5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
    6. Hospitalized, without oxygen supplement and without the need for continued medical care
    7. Not hospitalized
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 20, 2020)
  • Incidence of serious and non-serious adverse events. [ Time Frame: 30 days after enrolment ]
    Number of adverse events and number of patients with adverse events
  • Discontinuation due to adverse reactions [ Time Frame: 30 days after enrolment ]
    Number of adverse reactions that requires discontinuation of any drug in the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)
Official Title  ICMJE Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection
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 manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.
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 hospitalised patients with moderate to early severe COVID-19 infection, compared to the current standard of care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised, open-label, single-center, comparative trial of sarilumab plus standard of care vs. standard of care in a 2:1 ratio.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE
  • Drug: Sarilumab
    Single dose treatment with sarilumab 2 x 200 mg subcutaneously
    Other Names:
    • Kevzara
    • SAR153191
  • Other: Standar of care
    Usual clinical care
Study Arms  ICMJE
  • Experimental: Sarilumab plus standard of care
    Sarilumab 200 mg, 2 sc injections in pre-filled syringe or pen, single dose. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed
    Intervention: Drug: Sarilumab
  • Active Comparator: Standard of care
    Treatment with drugs or procedures in routine clinical practice
    Intervention: Other: Standar of care
Publications * Garcia-Vicuña R, Abad-Santos F, González-Alvaro I, Ramos-Lima F, Sanz JS. Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 9;21(1):772. doi: 10.1186/s13063-020-04588-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 4, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1. Fever ≥ 37.8ºC (tympanic)
    2. 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
    3. Lymphocytes <600 mm3
    4. Ferritin> 300 mcg / L that doubles in 24 hours
    5. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
    6. D-dimer (> 1 mg / L)
  • Informed verbal or administration consent 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04357808
Other Study ID Numbers  ICMJE SARCOVID
2020-001634-36 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria del Rosario Garcia de Vicuña Pinedo, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Sponsor  ICMJE Maria del Rosario Garcia de Vicuña Pinedo
Collaborators  ICMJE Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Investigators  ICMJE
Principal Investigator: Rosario Garcia de Vicuña, MD PhD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
PRS Account Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP