Clinical Trial of Sarilumab in Adults With COVID-19

• Status: Completed
• Trial end date: 2021-04-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Consejería de Salud y Familias - Junta de Andalucía; Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
• Treatments: Pharmaceutical Solutions

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