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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 : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
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

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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Sarilumab Other: Standar of care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
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
Drug: Sarilumab
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Other Names:
  • Kevzara
  • SAR153191

Active Comparator: Standard of care
Treatment with drugs or procedures in routine clinical practice
Other: Standar of care
Usual clinical care




Primary Outcome Measures :
  1. 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

  2. Duration of hospitalisation (days) [ Time Frame: 30 days from enrolment ]
    Days from the date of enrolment to the date of discharge

  3. Death [ Time Frame: 30 days from enrolment ]
    Number of deaths


Secondary Outcome Measures :
  1. Time to become afebrile (days) [ Time Frame: 30 days from enrolment ]
    Time to become afebrile for a minimum period of 48 hours, without antipyretics

  2. Time to non-invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to non-invasive mechanical ventilation

  3. Time to invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to invasive mechanical ventilation

  4. Time to independence from supplementary oxygen therapy (days) [ Time Frame: 30 days from enrolment ]
    Days from enrolment to supplementary oxygen therapy withdrawal

  5. 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


Other Outcome Measures:
  1. 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

  2. Discontinuation due to adverse reactions [ Time Frame: 30 days after enrolment ]
    Number of adverse reactions that requires discontinuation of any drug in the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357808


Contacts
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Contact: Rosario Garcia de Vicuña, MD PhD +34 91 5202473 mariadelrosario.garcia@salud.madrid.org
Contact: Jesús Sanz Sanz, MD PhD +34 91 5204014 jsanzsanz@salud.madrid.org

Locations
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Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Rosario Garcia de Vicuña, MD, PhD    +34915202438    mariadelrosario.garcia@salud.madid.org   
Sponsors and Collaborators
Maria del Rosario Garcia de Vicuña Pinedo
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Investigators
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Principal Investigator: Rosario Garcia de Vicuña, MD PhD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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Responsible Party: Maria del Rosario Garcia de Vicuña Pinedo, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT04357808    
Other Study ID Numbers: SARCOVID
2020-001634-36 ( EudraCT Number )
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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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
Keywords provided by Maria del Rosario Garcia de Vicuña Pinedo, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
COVID
SARS-CoV-2
coronavirus infections
sarilumab
IL-6 receptor inhibitors
Additional relevant MeSH terms:
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Infection