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NCT04357860 | COMPLETED | SARS-CoV 2

Clinical Trial of Sarilumab in Adults With COVID-19
Sponsor:

Maimonides 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

SARS-OF 2

SARS

Intervention/treatment

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]

Best available treatment

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome
Actual Study Start Date : 2020-04-28
Estimated Primary Completion Date : 2021-03-09
Estimated Study Completion Date : 2021-04-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Clinical Trial of Sarilumab in Adults With COVID-19

Location Details

NCT04357860

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How to Participate

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Locations

Not yet recruiting

Spain,

Reina Sofía University Hospital

Córdoba, Spain, 14004