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

NCT ID: NCT04357808

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2020-12-04

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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations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

Conditions

Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sarilumab

Intervention Type: DRUG

Single dose treatment with sarilumab 2 x 200 mg subcutaneously

Standard of care

Treatment with drugs or procedures in routine clinical practice

Group Type: ACTIVE_COMPARATOR

Standar of care

Intervention Type: OTHER

Usual clinical care

Interventions

Sarilumab

Single dose treatment with sarilumab 2 x 200 mg subcutaneously

Intervention Type: DRUG

Standar of care

Usual clinical care

Intervention Type: OTHER

Other Intervention Names

Kevzara; SAR153191

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

OTHER

Sponsor Role: collaborator

Maria del Rosario Garcia de Vicuña Pinedo

OTHER

Sponsor Role: lead

Responsible Party

Maria del Rosario Garcia de Vicuña Pinedo

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rosario Garcia de Vicuña, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Locations

Hospital Universitario de la Princesa

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35280907 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32907638 (View on PubMed)

Other Identifiers

2020-001634-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SARCOVID

Identifier Type: -

Identifier Source: org_study_id