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Clinical Trial of Sarilumab in Adults With COVID-19 (SARICOR)

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ClinicalTrials.gov Identifier: NCT04357860
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborators:
Consejería de Salud y Familias - Junta de Andalucía
Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Brief Summary:
Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.

Condition or disease Intervention/treatment Phase
SARS-CoV 2 SARS Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] Drug: Best available treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome
Estimated Study Start Date : April 27, 2020
Estimated Primary Completion Date : July 27, 2020
Estimated Study Completion Date : July 27, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
Experimental: Sarilumab 200 mg
Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose.
Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]
Best available treatment up to 14 days plus Sarilumab 200 mg

Experimental: Sarilumab 400 mg
Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose.
Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]
Best available treatment up to 14 days plus Sarilumab 400 mg

Active Comparator: Control
Subjects treated with the best available treatment up to 14 days.
Drug: Best available treatment
Best available treatment up to 14 days




Primary Outcome Measures :
  1. Ventilation requirements [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]

    Proportion of patients requiring or time (in days) until required:

    • High flow nasal oxygenation (HFNO)
    • Non-invasive mechanical ventilation type BiPAP
    • Non-invasive mechanical ventilation type CPAP
    • Invasive mechanical ventilation


Secondary Outcome Measures :
  1. Crude mortality [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Crude mortality at 28 days

  2. Time to clinical improvement [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]

    Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories:

    1. - Not hospitalized with normal activity
    2. - Not hospitalized but unable to have normal activity
    3. - Hospitalized, without requiring oxygen supplementation
    4. - Hospitalized, requiring oxygen supplementation
    5. - Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both
    6. - Hospitalized requiring ECMO, invasive mechanical ventilation or both
    7. - Death

  3. Time until improvement in oxygenation [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]

    Time (in days) until improvement in oxygenation for at least 48 hours:

    • Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD
    • Time to absence of oxygen requirement to maintain saturation in ambient air ≥ 93%
    • Number of days in need of supplemental oxygen

  4. Proportion of patients requiring invasive mechanical ventilation [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Proportion of patients requiring invasive mechanical ventilation in the trial

  5. Proportion of patients having negative COVID-19 CRP at each visit [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Proportion of patients having negative COVID-19 CRP at each visit of the trial

  6. Mean of serum cytokine levels [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF and PAI-1

  7. Adverse events related to medication and its administration [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Incidence of adverse events related to medication and its administration

  8. Incidence in the appearance of serious bacterial, fungal or opportunistic infections [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Incidence in the appearance of serious bacterial, fungal or opportunistic infections in the subjects

  9. Incidence of perforation of the gastrointestinal tract [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Incidence of perforation of the gastrointestinal tract in subjects

  10. Leukocyte and neutrophil count [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Leukocyte and neutrophil count mean

  11. Hemoglobin levels [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Mean hemoglobin levels

  12. Platelet count [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Platelet count mean

  13. Levels of creatinemia [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Average levels of creatinemia

  14. Bilirubin levels [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    Average bilirubin levels

  15. ALT and AST levels [ Time Frame: At day 28 or when the subject is discharged (whichever occurs first) ]
    ALT and AST average levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and <75 years
  • Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
  • Interstitial pneumonia confirmed by chest radiography or CT
  • IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
  • Negative pregnancy test in women of childbearing age
  • Signature of informed consent

Exclusion Criteria:

  • SOFA score> 6 points
  • Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
  • Neutrophil count <2 x 103 / μL
  • Platelet count <100 x 103 / μL
  • ALT or AST levels> 5 times the upper limit of normal
  • Severe renal failure (CrCr <30 ml / min)
  • Active bacterial infectious process
  • Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
  • History of intestinal ulcer or diverticulitis
  • History of hypersensitivity reactions to Sarilumab or its excipients
  • Treatment with TNF antagonists
  • Previous treatment with anti-IL6 in the previous 30 days
  • Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
  • Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
  • Patients on immunosuppressive treatment for any cause
  • HIV-infected patients with CD4 <200 / mm3
  • Past or current history of autoimmune disease or systemic inflammatory disease
  • Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
  • Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
  • Pregnancy
  • Any other condition that, in clinical judgment, prevents adherence to the patient's protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357860


Contacts
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Contact: Antonio Luque 0034671596070 uicec@imibic.org
Contact: José Carlos Garrido Gracia uicec@imibic.org

Locations
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Spain
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Contact: Rafael León López, MD         
Contact: Antonio Luque    0034671596070    uicec@imibic.org   
Principal Investigator: Rafael León López, MD         
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Consejería de Salud y Familias - Junta de Andalucía
Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
Investigators
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Study Director: Julián de la Torre Cisneros, MD Hospital Universitario Reina Sofía
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT04357860    
Other Study ID Numbers: SARICOR
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the information will be published and it will be available in open access.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After the end of the trial.
Access Criteria: Contact uicec@imibic.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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