EUCTR2021-002612-31-IT进行中（未招募）1 期
Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO) - Efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO Trial)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •oFever >37.3 °C
- •oSore throat
- •oBody pain or muscle pain
- •oLoss of taste or smell
- •oNausea or vomiting
- •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
排除标准
- •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.
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