Covid-19 infection MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Evusheld
Product Name: Evusheld
Product Code: [-]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tixagevimab
Current Sponsor code: -
Concentration unit: mg milligram(s)
C
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the extent and persistence over time of the humoral and cellular immune response in subjects who received MAbs after SARS-CoV-2 infection and had a different vaccination status at the time of infection and evaluate the impact of different revaccination times on the humoral and cellular response.;Secondary Objective: -;Primary end point(s): Evaluation of the effectiveness of revaccination at 4 versus 12 months on the temporal kinetics of humoral and cellular response markers.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Evaluate the anti-N IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) Evaluate the anti-S IgG antibody titer at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) Evaluate the titer of neutralizing antibodies at 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) Evaluate cellular immunity to S and N with IGRA test at 0, 4, 12 months after MAbs infusion;Timepoint(s) of evaluation of this end point: 1) 0, 1, 4, 6, 9, 12 months after the MAbs infusion 2) 0, 1, 4, 6, 9, 12 months after the MAbs infusion 3) 0, 1, 4, 6, 9, 12 months after the MAbs infusion 4) 0, 4, 12 months after MAbs infusion | — |
Countries
Italy
Contacts
Public ContactImmunodeficienze virali
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed