Status:
COMPLETED
Clinical Trial of Sarilumab in Adults With COVID-19
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Junta de Andalucia
Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
Conditions:
SARS-CoV 2
SARS
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04357860
Start Date
April 28 2020
End Date
April 6 2021
Last Update
July 7 2021
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004