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OpenTrials
Completed

NCT Number: NCT04357808

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

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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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.

Treatment and study plan

Sarilumab

Drug

Single dose treatment with sarilumab 2 x 200 mg subcutaneously

Other names: Kevzara, SAR153191

Standar of care

Other

Usual clinical care

Primary outcomes

  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

    • Death;
    • Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    • Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    • 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 outcomes

  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:

    • Death
    • Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    • Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
    • Hospitalized with oxygen supplement
    • Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
    • Hospitalized, without oxygen supplement and without the need for continued medical care
    • Not hospitalized

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Maria del Rosario Garcia de Vicuña Pinedo

Other

Collaborators

  • Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

Registry information

Official study title

Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection

Acronym: SARCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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