COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: .
Product Name: Bamlanivimab
Product Code: [Bamlanivimab]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Bamlanivimab
CAS Number: 2423943-37-5
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Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following general inclusion (GI) criteria apply: • Age = 50 years • Informed consent by the subject or legally authorized representative • Laboratory-confirmed SARS-CoV-2 infection, as determined by PCR or other commercial or public health assay in any specimen, no more than 4 days prior to the study drug administration • Peripheral oxygen saturation = 94% on room air and not requiring supplemental oxygen • Onset of symptom is no more than 4 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one of the following (but not limited to) SARS-CoV-2 infection-associated symptom (FDA, September 2020): o Nasal obstruction or congestion o Cough o Fever >37.3 °C o Sore throat o Body pain or muscle pain o Headache o Loss of taste or smell o Nausea or vomiting o Diarrhoea Are the trial subjects under 18? no 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 460 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: • AIFA (Italian Medicine Agency) criteria for the use of monoclonal antibodies (the definitions of the criteria may change before the start of the study on the basis of new communications from AIFA for the definition of these criteria) o Body Mass Index (BMI) =35 o Chronic kidney disease o Uncontrolled diabetes o Primary immunodeficiencies o Secondary immunodeficiencies o Cardio-cerebrovascular disease in the patient at least 55 years of age o COPD and / or other chronic respiratory diseases in the patient at least 55 years of age • Previously or currently hospitalized or requiring hospitalization • Respiratory distress with respiratory rate = 25 breaths/min • Heart rate = 125 beats per minute • Peripheral oxygen saturation = 93% on room air at sea level • Known allergies to any of the components used in the formulation of the interventions • Hemodynamic instability requiring use of pressors within 24 hours of randomization • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that could potentially lead to hospitalization in within 30 days • Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days • History of a positive SARS-CoV-2 serology test • History of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study • Other investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing • Previous treatment with a SARS-CoV-2 specific monoclonal antibody • History of convalescent COVID-19 plasma treatment • Previous SARS-CoV-2 vaccination • Participation, within the last 30 days, in a clinical study involving an investigational intervention • Pregnancy or breast feeding • Investigator site personnel directly affiliated with this study • Sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose • Inability to participate to the study follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is a phase 3, multicentre, randomized, adaptive trial to investigate the efficacy of bamlanivimab / etesevimab (700 mg / 1400 mg) and casirivimab / imdevimab (1200 mg / 1200 mg) given at an early stage. (within 4 days of onset of symptoms) of COVID-19 (symptomatic stage without the need for oxygen supplementation or hospitalization) in preventing disease progression (need for oxygen therapy supplementation and / or hospitalization and / or death) in patients over 50 years of age not included in the administration criteria indicated by AIFA.;Secondary Objective: Secondary objetives of the study are the following: - To compare the efficacy of experimental treatments versus placebo with respect to other relevant clinical endpoints. - To compare the effectiveness of experimental treatments compared to placebo with regard to laboratory endpoints. - To compare the efficacy of experimental treatments versus placebo with regard to negative result of the nasopharyngeal swab for the detection of SARS-CoV-2. - To compare the efficacy of experimental treatments versus placebo with respect to patient-reported endpoints.;Primary end point(s): COVID-19 disease progression, defined as (1) hospitalization or (2) need for supplemental oxygen therapy at home or (3) death, within 14 days of randomization;Timepoint(s) of evaluation of this end point: Within 14 days of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Creatinine (µmol / L) • ALT, Aspartate aminotransferase (U / L) • ALP, Alkaline Phosphatase (U / L) • Amylase (U / L) • Total bilirubin (µmol / L) • D-dimer (µg / L) • Glucose (mmol / L) • Ferritin (µg / L) • LDH, Lactate dehydrogenase (U / L) • Sodium (mmol / L) • Potassium (mmol / L) • CRP, Reactive Protein C (mg / L) • Procalcitonin (ng / mL) • Hemoglobin (g / dL) • Leukocytes (x 109 / L), neutrophils (x 109 / L), • Lymphocytes (x 109 / L) • Platelets (x 109 / L); Nasopharyngeal swab negative molecular testing (PCR) for SARS-CoV-2 at days 7, 14, 21, 28, 90 after randomization; • Number of visits to the ER without subsequent hospitalization within 28 days of randomization • Duration of supplemental oxygen therapy within 90 days from the randomization • Duration of any hospitalization within 90 days from the randomization • Need for non-invasive ventilation within 28 days from randomization • Duration of non-invasive ventilation within 90 days from randomization • Need for mechanical ventilation within 28 from randomization • Duration of mechanical ventilation within 90 days from randomization • Mortality at 28 and 90 days from randomization; • Duration of fever within 90 days from randomization • Duration of symptoms within 90 days from randomization • Days of absence from work (including smart working) within 90 days from randomisation (only in the case of employment) • Measurement of quality of life associated with health status by administering the SF-36 questionnaire (Short Form-36 Health Survey) at day 28/90 from randomization; Adverse events leading to interruption of the drug infusion or serious adverse events;Timepoint(s) of evaluation of this end point: At day 7, 14, 28 after randomization; At day 7/14/21/28 after randomization; Within 28/90 days of randomization; At day 28/90 after randomization; For all the duration of the sperimental drug infusion | — |
Countries
Italy
Contacts
Public ContactUOC Malattie Infettive
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed