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

Maria del Rosario Garcia de Vicuña Pinedo

Status and phase: Completed; Phase 2

Conditions: Covid-19

Treatments: Other: Standar of care; Drug: Sarilumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04357808

2020-001634-36 (EudraCT Number)

SARCOVID

Details and patient eligibility

About

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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sarilumab plus standard of care

Experimental group

Description:

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

Treatment:

Drug: Sarilumab

Standard of care

Active Comparator group

Description:

Treatment with drugs or procedures in routine clinical practice

Treatment:

Other: Standar of care