Covid 19 Infection MedDRA version: 23.1 Level: PT Classification code 10084458 Term: COVID-19 prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Sotrovimab
Product Code: [-]
Pharmaceutical Form: Infusion
Current Sponsor code: -
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >=18 years of age at the time of obtaining informed consent. - Non-responders subjects (absence of antibodies response), aged 65 years or more, to a mRNA anti SARS-CoV-2 vaccination 1 month after the completion of the vaccination schedule and without an immunocompromising condition - Non-responders subjects (absence of antibodies response) to a mRNA anti SARS-CoV-2 vaccination 1 month after the completion of the vaccination schedule and with an immunocompromising condition, including, but not limited to, the following: a. Primary and secondary immunodeficiencies involving adaptive immunity b. Splenectomy or functional asplenia [e.g., sickle cell disease] c. B cell directed therapies (e.g., blocking monoclonal antibodies against CD20 or CD22, bispecific agents like blinatumomab, CD19 or CD22-directed chimeric antigen receptor T cell [CAR-T; at least 2 weeks since the last administration] therapies, Bruton tyrosine kinase [BTK] inhibitors) d. T-cell-directed therapies (e.g., calcineurin inhibitors, anti-thymocyte globulin, alemtuzumab) e. Many chemotherapy regimens f. High-dose corticosteroids (=20 mg per dose or >2 mg/kg/day daily prednisone or equivalent) g. Hematopoietic cell transplantation (HCT), especially within the first three to six months after autologous HCT and often longer after allogeneic HCT h. Underlying aberrant immunity (e.g., graft-vs.-host disease, graft rejection, absent or incomplete immune reconstitution, neutropenia ANC =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - History of prior positive SARS-CoV-2 RT-PCR or antigen test or history of positive SARS-CoV-2 serology test including during screening. - Febrile illness with or without respiratory symptoms (e.g., cough, nasal congestion) within 7 days prior to randomization - Unstable medical condition and not expected to survive for the duration of study participation as judged by the investigator - Known hypersensitivity to any constituent present in the investigational product - Previous anaphylaxis or hypersensitivity to a monoclonal antibody - Contemporary CAR-T treatment - Anti-S Ab the day of vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the feasibility, safety and tolerability of VIR-7831 administered IV as Pre-Exposure Prophylaxis (PrEP) in non-responders individuals to a mRNA anti-SARS-CoV-2 vaccine, including subjects non-responders to the third dose of vaccine;Secondary Objective: -To evaluate the immunogenicity of VIR-7831 over time -To evaluate the serum pharmacokinetics (PK) of VIR-7831 -Analysis of the viro-immunological characteristics, with particular attention to the SARS-CoV-2 sequence and the profile of immune correlates of subjects with confirmed SARS-CoV-2 infection;Primary end point(s): -Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) -Proportion of participants who have a detectable IgG anti-RBD at day 29, 85 and 180 after the Vir-7831 administration and magnitude of this titres -Analysis of the cell-mediated response to the Spike antigen (cytokine release test after specific stimulation, flow cytofluorimetry) at day 29, 85 and 180 after the Vir-7831 administration -Serum PK of VIR-7831 administered IV (PK parameters) at day of infusion [End-of-Infusion (EOI)], Day 8, Day 29, and Day 85 +/- 3 days window -Incidence of anti-N IgG serum conversions on the day of administration and subsequently at 1 month, 3 e 6 months -Number of symptomatic participants with a positive molecular test for SARS-CoV-2 (according to NIH criteria) at day 29, 85 and 180 -Death associated with COVID-19 at day 29, 85 and 180 after -All-cause mortality;Timepoint(s) of evaluation of this end point: - In each period of the study; - on days 29, 85 and 180 from the administration of Vir-7831; - on days 29.85 and 180; - day 8, 29, and day 85 (with a window of +/- 3 days); - on the day of administration and after 1 month, 3 and 6 months - on days 29.85 and 180; - on days 29.85 and 180; - In each period of the study | — |
Countries
Italy
Contacts
Public ContactImmunodeficienze virali
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed