Study on the Use of Sarilumab in Patients With COVID-19 Infection

NCT04386239 | Withdrawn Early Phase 1

• 1 other identifier: COVID-SARI-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Sarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is administered subcutaneously every two weeks for the treatment of moderate to severe active rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in the recently published experiences, the need to rapidly find alternative therapies to manage the complications of Covid-19 infection remains extremely high. The lack of clinical experience on the usage of sarilumab in such patients prevents the possibility of adopting early access programs for using commercially available sarilumab (prefilled syringe) packs in patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in Covid-19 pneumonia.

Conditions

COVID19

Keywords

Coronavirus; Pandemic; Lombardy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who show an improvement of the respiratory function

  Clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as ≥30% decrease in oxygen requirement compared to baseline (as defined as the ratio of O2 flow through the Venturi mask).

  6 weeks

Secondary Outcomes (6)

• Evaluation of the time to resolution of fever

  6 weeks

• Evaluation of the viral load on blood and sputum for COVID-19

  Before administration of sarilumab, 48 hours and 96 hours after administration

• Evaluation of the plasma concentration of GM-CSF

  Pre-treatment and 96 and 120 hours post-treatment

• Evaluation of the plasma concentration of Il-6

  Pre-treatment and 96 and 120 hours post-treatment

• Evaluation of the plasma concentration of TNF-α

  Pre-treatment and 96 and 120 hours post-treatment

Study Arms (1)

Covid-19

EXPERIMENTAL

Patients with documented (chest X-Ray or Computed Tomography scan) Covid-19 (Polymerase Chain Reaction+ swab test) interstitial pneumonia and BCRSS ≥3 and \<4 will be requested consent to the study.

Drug: Sarilumab Prefilled Syringe

Interventions

Sarilumab Prefilled Syringe DRUG

Sarilumab administration must be associated with an antiviral treatment as defined by the treatment protocol suggested by the SIMET Experts group 4 and AIFA recommendations: chloroquine 500 mg 1 tablet twice daily or hydroxychloroquine 400 mg 1 tablet twice daily in the first day and then 200 mg 1 tablet twice daily.

Also known as: Sarilumab

Covid-19

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 85 years.
• Documented (chest X-Ray or TC scan), severe (BCRSS ≥3 and \<4) interstitial pneumonia with respiratory failure (requiring supplemental oxygen) with positive Covid-19 swab testing.
• Worsening of respiratory exchanges such as to require ventilation with Venturi mask \>31% (6L/minute).
• Increased levels of D-dimer (\> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.
• Signed informed consent.

You may not qualify if:

• Age \< 18 years or ≥ 85 years.
• AST / ALT \> 5x Upper normal limit.
• Neutrophil count lower than 500 cells / mL.
• Platelet count lower than 50,000 cells / mL.
• Documented sepsis due to infections other than Covid-19.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

Divisione Clinicizzata di Malattie Infettive, ASST FBF-Sacco

Milan, MI, 20157, Italy

Location

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

• Massimo Galli, Professor

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Model Details: Monocentric, escalation dose

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)