Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19

NCT04661527 | Unknown Phase 2

• 2 other identifiers: STRIKESARS-COV2020-001255-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).

Conditions

COVID-19 Drug Treatment

Outcome Measures

Primary Outcomes (1)

• Change in a severity rating on a 7-point ordinal scale

  Impact of sarilumab on the progression of COVID-19 associated respiratory failure. A significant improvement in a 7-point severity index is anticipated to occur with treatment with sarilumab.

  15 days

Secondary Outcomes (23)

• Percentage of patients reporting each severity rating on a 7-point severity ordinal scale

  28 days

• Duration of mechanical ventilation

  28 days

• Evaluate the safety of sarilumab in patients with severe pneumonia caused by COVID 19

  28 days

• Number of ventilator free days in the first 28 days

  28 days

• Patients requiring mechanical ventilation

  28 days

Study Arms (1)

Sarilumab arm

EXPERIMENTAL

Drug: Sarilumab

Interventions

Sarilumab DRUG

Treatment with Sarilumab 200 mg IV x 2 doses 24 hours apart for first 5 patients. If no severe AE and no significant improvement within 48 hours, the dose will be increased for subsequent patients to 400 mg IV for the first dose and 200 mg or 400 mg IV for the second dose 24 hours later. Te second dose will be decided at the investigators discretion.

Also known as: Kevzara®

Sarilumab arm

Eligibility Criteria

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

You may qualify if:

• Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
• In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.
• Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
• Negative pregnancy test in case of fertile women\*
• Age \>= 18
• Infection by COVID-19 confirmed by rtPCR or other validated tests
• Hospitalized (or documentation of a plan to admit to the hospital if the patient is in the emergency department) with illness of any duration, with evidence of pneumonia, and severe disease as defined by at least one of the following:
• High oxygen requirements (face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula)
• Lymphocytes \< 0.8 x 109/L
• Serum ferritin \> 300ng/mL
• Increased levels of D-dimer (\> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.
• CPR \> 10 mg/dL, or increasing over 24 hours

You may not qualify if:

• Hypersensitivity to the active substance or any of the excipients listed in section 6
• Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days
• Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
• Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
• Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
• Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.
• Intravenous immunoglobulin (IVIG) within the past 5 months or plans to receive during the study period
• Current use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day
• Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents
• Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin
• AST/ALT values \> 5 x normal.
• Neutropenia (\< 0.5 x 109/L).
• Sever thrombocytopenia (\< 50 x 109/L).
• Sepsis caused by an alternative pathogen.
• Diverticulitis with risk of perforation.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Sanofi: collaborator
• Hospital Universitario Infanta Leonor: collaborator

Study Sites (2)

Clínica Universidad de Navarra, Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

RECRUITING

MeSH Terms

Interventions

sarilumab

Study Officials

• Javier J Zulueta, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier J Zulueta, MD

CONTACT

+34948255400; jzulueta@unav.es

Gabriel Canel

CONTACT

+34948255400; gcanelc@unav.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU)

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: December 10, 2020
• Study Start: April 22, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-04

Locations

ES (2)