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

Primary Purpose

Covid-19

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Sarilumab
Standar of care
Sponsored by
Maria del Rosario Garcia de Vicuña Pinedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring COVID, SARS-CoV-2, coronavirus infections, sarilumab, IL-6 receptor inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario de la Princesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sarilumab plus standard of care

Standard of care

Arm 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 with drugs or procedures in routine clinical practice

Outcomes

Primary Outcome Measures

Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation
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
Duration of hospitalisation (days)
Days from the date of enrolment to the date of discharge
Death
Number of deaths

Secondary Outcome Measures

Time to become afebrile (days)
Time to become afebrile for a minimum period of 48 hours, without antipyretics
Time to non-invasive mechanical ventilation (days)
Days from enrolment to non-invasive mechanical ventilation
Time to invasive mechanical ventilation (days)
Days from enrolment to invasive mechanical ventilation
Time to independence from supplementary oxygen therapy (days)
Days from enrolment to supplementary oxygen therapy withdrawal
Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation
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

Full Information

First Posted
April 14, 2020
Last Updated
February 10, 2021
Sponsor
Maria del Rosario Garcia de Vicuña Pinedo
Collaborators
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
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1. Study Identification

Unique Protocol Identification Number
NCT04357808
Brief Title
Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)
Acronym
SARCOVID
Official Title
Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria del Rosario Garcia de Vicuña Pinedo
Collaborators
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
COVID, SARS-CoV-2, coronavirus infections, sarilumab, IL-6 receptor inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarilumab plus standard of care
Arm Type
Experimental
Arm 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
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Treatment with drugs or procedures in routine clinical practice
Intervention Type
Drug
Intervention Name(s)
Sarilumab
Other Intervention Name(s)
Kevzara, SAR153191
Intervention Description
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Intervention Type
Other
Intervention Name(s)
Standar of care
Intervention Description
Usual clinical care
Primary Outcome Measure Information:
Title
Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation
Description
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
Time Frame
7 days from enrolment
Title
Duration of hospitalisation (days)
Description
Days from the date of enrolment to the date of discharge
Time Frame
30 days from enrolment
Title
Death
Description
Number of deaths
Time Frame
30 days from enrolment
Secondary Outcome Measure Information:
Title
Time to become afebrile (days)
Description
Time to become afebrile for a minimum period of 48 hours, without antipyretics
Time Frame
30 days from enrolment
Title
Time to non-invasive mechanical ventilation (days)
Description
Days from enrolment to non-invasive mechanical ventilation
Time Frame
30 days from enrolment
Title
Time to invasive mechanical ventilation (days)
Description
Days from enrolment to invasive mechanical ventilation
Time Frame
30 days from enrolment
Title
Time to independence from supplementary oxygen therapy (days)
Description
Days from enrolment to supplementary oxygen therapy withdrawal
Time Frame
30 days from enrolment
Title
Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation
Description
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
Time Frame
14 days from enrolment
Other Pre-specified Outcome Measures:
Title
Incidence of serious and non-serious adverse events.
Description
Number of adverse events and number of patients with adverse events
Time Frame
30 days after enrolment
Title
Discontinuation due to adverse reactions
Description
Number of adverse reactions that requires discontinuation of any drug in the study
Time Frame
30 days after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario Garcia de Vicuña, MD PhD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35280907
Citation
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.
Results Reference
derived
PubMed Identifier
32907638
Citation
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.
Results Reference
derived

Learn more about this trial

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

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