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

Phase 1

• Conditions: Covid-19 infection; MedDRA version: 20.0Level: HLGTClassification code: 10047438Term: Viral infectious disorders Class: 10021881; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-514071-17-00
• Lead Sponsor: ational Institute For Infectious Diseases Lazzaro Spallanzani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

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

Exclusion Criteria

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified