COVID-19 infection MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Imdevimab
Product Code: [-]
Pharmaceutical Form: Concentrate for solution for injection/infusion
Current Sponsor code: -
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years; - Signed informed consent provided by the patient, or by the patient’s legally authorized representative(s), as applicable; - Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by RT-PCR test); patients must have sample taken for test confirming viral infection no more than 3 days prior to randomization; - Having one or more mild or moderate COVID-19 symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion for no more than 7 days; - Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method (s) of contraception (Appendix C); o Highly effective contraceptive measures in women include: stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening, Intrauterine device (IUD), Intrauterine hormone-releasing system (IUS), Bilateral tubal ligation, Vasectomized partner and/or Sexual abstinence. o Highly effective contraceptive measures in men include: study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. 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 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 550
Exclusion criteria
Exclusion criteria: - Having one of the following conditions: o Body mass index (BMI) >30 o Chronic kidney disease o Uncontrolled diabetes o Having immunosuppressive disease or receiving immunosuppressive treatment - Being >65 years old and having one of the above mentioned conditions - Being >55 years old and having one of the following conditions: o Cardiovascular or cerebrovascular disease (including hypertension with concomitant organ damage) o Chronic obstructive pulmonary disease (COPD) or other chronic respiratory diseases - Pregnancy/lactation; - Have oxygen saturation (SpO2) less than or equal to (=)93 percent (%) on room air and persisting for more than 7 days; - Virological diagnosis of SARS-CoV-2 infection (SARS-CoV-2 infection confirmed by PCR test) more than 3 days before; - Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study; - Enrolment in another concurrent clinical interventional study within 30 days; - Existence of any life-threatening co-morbidity or any other medical condition, which, in the opinion of the investigator, makes the patient unsuitable for the study; - Having known allergy or hypersensitivity to components of study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MoAbs in term reduction of occurrence of death, hospitalization and severe COVD-19 by day 29 after randomization;Secondary Objective: -To assess the effect of MoAbs in the prevention of hospitalization for COVID-19 by day 90 after -To assess the effect of MoAbs to reduce SARS-CoV-2 detection or levels of RNA in nasal swabs -To assess the effect of MoAbs on symptom resolution -To evaluate differences in symptom duration between the MoAbs and SoC through day 29 -To evaluate differences in long-term symptoms and duration between the MoAbs and SoC after viral clearance -To investigate the humoral response to non-Spike SARS-CoV-2 antigens -To investigate the T-cell response to S and N viral antigens in a subgroup of enrolled patients -To explore if baseline and follow-up hematology, chemistry, coagulation, viral, and inflammatory biomarkers are associated with clinical and virologic outcomes in relation to any MoAbs in the study protocol -Viral genotypic analysis over time and phenotypic characterization of treatment-emergent mutations.;Primary end point(s): A composite endpoint of either severe COVID-19 or hospitalization or access in an emergency department or death from any cause by day 29 after randomization. Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, AND lung infiltrates) and hypoxemia (SpO2 < 92% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher;Timepoint(s) of evaluation of this end point: 29 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of participants who experience hospitalization or Emergency Room (ER) visit within day 29 and within 90 days; - Proportion of participants experiencing severe COVID-19 by day 29 after randomization; - Variation of SARS-CoV-2 viral load measured by semi-quantitative RT-PCR between day of randomization and day 7, 14 and 29; - Proportion of participant with undetectable SARS-CoV-2 RNA at day 7, 14 and 29 after randomization; - Variation of symptoms score from day of randomization to days 7, 14, and 29 after randomization; - Proportion of participants demonstrating symptom resolution (i.e. scoring 0 in the WHO scale) at Days 7, 14 and 29 after randomization; - Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 29 after randomization; - Proportion of participants with severe adverse events (grade = 3 according to CTCAE) at day 7, 29 after randomization; - Variation of Hematology, chemistry, coagulation, and inflammatory markers between the day of randomization and day 7, 29 after randomization; - Proportion of SARS-CoV-2 spike mutation gene (including D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F and N439K) among participant experiencing the primary endpoint; - Proportion of SARS-CoV-2 spike mutation gene (including D614G, N501Y, N501Y.V2, L452Y, L452R, E484K/Q, Y453F and N439K) among participant with a detectable SARS-COV-2 viral load at day 29 after randomization;Timepoint(s) of evaluation of this end point: - within day 29 and within 90 days; - by day 29 after randomization; - between day of randomization and day 7, 14 and 29; - at day 7, 14 and 29 after randomization; - from day of randomization to days 7, 14, and 29 after randomization; - at Days 7, 14 and 29 after randomization; - at day 7, 29 after randomization; - at day 7, 29 after randomization; - between the day of randomization and day 7, 29 after randomization; - at day 29; - at day 29 after randomization | — |
Countries
Italy
Contacts
Public ContactImmunodeficienze virali
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed