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

NCT04357808 | Completed Phase 2

• 2 other identifiers: SARCOVID2020-001634-36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations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

Conditions

Covid-19

Keywords

COVID; SARS-CoV-2; coronavirus infections; sarilumab; IL-6 receptor inhibitors

Outcome Measures

Primary Outcomes (3)

• Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation

  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

  7 days from enrolment

• Duration of hospitalisation (days)

  Days from the date of enrolment to the date of discharge

  30 days from enrolment

• Death

  Number of deaths

  30 days from enrolment

Secondary Outcomes (5)

• Time to become afebrile (days)

  30 days from enrolment

• Time to non-invasive mechanical ventilation (days)

  30 days from enrolment

• Time to invasive mechanical ventilation (days)

  30 days from enrolment

• Time to independence from supplementary oxygen therapy (days)

  30 days from enrolment

• Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation

  14 days from enrolment

Other Outcomes (2)

• Incidence of serious and non-serious adverse events.

  30 days after enrolment

• Discontinuation due to adverse reactions

  30 days after enrolment

Study Arms (2)

Sarilumab plus standard of care

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

Treatment with drugs or procedures in routine clinical practice

Other: Standar of care

Interventions

Sarilumab DRUG

Single dose treatment with sarilumab 2 x 200 mg subcutaneously

Also known as: Kevzara, SAR153191

Sarilumab plus standard of care

Standar of care OTHER

Usual clinical care

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria del Rosario Garcia de Vicuña Pinedo: lead
• Instituto de Investigación Sanitaria Hospital Universitario de la Princesa: collaborator

Study Sites (1)

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Related Publications (2)

• Garcia-Vicuna R, Rodriguez-Garcia SC, Abad-Santos F, Bautista Hernandez A, Garcia-Fraile L, Barrios Blandino A, Gutierrez Liarte A, Alonso-Perez T, Cardenoso L, Alfranca A, Mejia-Abril G, Sanz Sanz J, Gonzalez-Alvaro I. Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial. Front Med (Lausanne). 2022 Feb 23;9:819621. doi: 10.3389/fmed.2022.819621. eCollection 2022.

  PMID: 35280907 DERIVED

• Garcia-Vicuna R, Abad-Santos F, Gonzalez-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.

  PMID: 32907638 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rosario Garcia de Vicuña, MD PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomised, open-label, single-center, comparative trial of sarilumab plus standard of care vs. standard of care in a 2:1 ratio.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 22, 2020
• Study Start: April 13, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 4, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

ES (1)