Tozinameran for COVID-19

Inclusion criteria

• {"criterion_text":"- 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. 18 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.\n- 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

• {"criterion_text":"- Patients under 18 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)."}

Primary endpoints

• {"endpoint_text":"- Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion","definition_or_measurement_approach":"Measurement of anti-N IgG antibody titer at specified timepoints (0, 1, 4, 6, 9, 12 months) after MAbs infusion."}
• {"endpoint_text":"- 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion","definition_or_measurement_approach":"Measurement of anti-S IgG antibody titer at specified timepoints (0, 1, 4, 6, 9, 12 months) after MAbs infusion."}
• {"endpoint_text":"- 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion","definition_or_measurement_approach":"Measurement of neutralizing antibody titers at specified timepoints (0, 1, 4, 6, 9, 12 months) after MAbs infusion."}
• {"endpoint_text":"- 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion","definition_or_measurement_approach":"Assessment of cellular immunity to S and N using IGRA test at 0, 4, and 12 months after MAbs infusion."}

Italy

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

14-01-2025

Processing Time Days

196

Number Of Sites

1

Number Of Participants

150

Primary sponsor

Full Name

National Institute For Infectious Diseases Lazzaro Spallanzani

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy