Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO)
- Conditions
- COVID-19MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-002612-31-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1260
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):
oNasal obstruction or congestion
oCough
oFever >37.3 °C
oSore throat
oBody pain or muscle pain
oHeadache
oLoss of taste or smell
oNausea or vomiting
oDiarrhoea
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
•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)
oBody Mass Index (BMI) =35
oChronic kidney disease
oUncontrolled diabetes
oPrimary immunodeficiencies
oSecondary immunodeficiencies
oCardio-cerebrovascular disease in the patient at least 55 years of age
oCOPD 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method