Temporal kinetics of antibody and cellular response markers and relative impact ofrevaccination in patients recovered from COVID-19 after treatment with monoclonalantibodies - Renoir

ational Institute For Infectious Diseases Lazzaro Spallanzani0 个研究点目标入组 83 人开始时间: 2024年6月12日最近更新: 2024年8月21日

适应症

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•The subjects eligible for inclusion in the study are patients diagnosed with COVID-19 who meet the access criteria established by the Ministry / AIFA / Regions Program, with the following access criteria [10] (In case of changes, the criteria inclusion will be modified accordingly): a. 12 year old patients and older with laboratory confirmed SARS-CoV-2 infection and mild or moderate COVID-19 disease onset within 7 days of evaluation who are at high risk for severe COVID-19 infection. Possible risk factors include the following: • body mass index (BMI) =30, or> 95th percentile for age and gender • chronic renal failure • uncontrolled diabetes mellitus (HbA1c> 9.0% 75 mmol / mol) or with chronic complications • primary or secondary immunodeficiency • age> 65 years • cardio-cerebrovascular disease • chronic obstructive pulmonary disease and / or other chronic respiratory disease • chronic liver disease • hemoglobinopathies • neurodevelopmental pathologies and neurodegenerative pathologies. b. Treatment is possible beyond 7 days from onset only in subjects with immunodeficiency who have: negative SARS-COV-2 serology and prolonged positivity to molecular swab

•- Patients under 12 year old - Inability to sign informed consent - hospitalized for COVID-19 - Have any concomitant serious systemic disease, condition or disorder which, in the opinion of the investigator, should preclude participation in this study - known allergy or hypersensitivity to the components of the study drug - Unmanageable drug interactions to treatment drugs (Annex 4).

发起方

ational Institute For Infectious Diseases Lazzaro Spallanzani