A phase 3, multicentre, single-blinded, randomized controlled study to compare the efficacy and safety of Casirivimab and Imdevimab or Bamlanivimab and Etesevimab or Sotrovimab in COVID-19 home patients at high risk of hospitalization. - Monoclonal Antibodies In COVID-19: MAI COVID-19

AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA0 个研究点目标入组 552 人开始时间: 2022年1月26日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) for all variants, except for beta and gamma. Positive patients will be considered eligible even when the information on variants is not timely available because of technical or organizational issues.
•2. Age =18 years of age at the time of randomization
•3. Are not hospitalized at the time of randomization
•4. Have one or more mild or moderate COVID-19 symptoms according to NIH classification, which onset within <10 days: ¿ Fever (>37.5 °C) ¿ Cough ¿ Sore throat ¿ Malaise ¿ Headache ¿ Muscle pain ¿ Gastrointestinal symptoms ¿ Shortness of breath with exertion
•5. Meet at least one of the following criteria, which define patients at high risk for progressing to severe COVID-19 and/or hospitalization: ¿ Body Mass Index (BMI) >30 ¿ Chronic kidney disease ¿ Diabetes ¿ Primary or secondary Immunodeficiency ¿ =55 years of age and at least of the following criteria: o cardiovascular disease, OR o hypertension, OR o chronic obstructive pulmonary disease/other chronic respiratory disease. ¿ =65 years of age
•6. Signed informed consent
•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 552
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 552

•1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) for variants beta and gamma
•2. Have severe COVID-19 requiring hospital admission or access to the emergency room. Severe COVID-19 is defined as one of the following clinical features: SpO2 = 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate =30 per minute, heart rate =125 per minute
•3. Require oxygen therapy due to COVID-19, or require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
•4. Require mechanical ventilation or anticipated impending need for mechanical ventilation
•5. Have received any dose of vaccine antiSARS-CoV-2 within < 15 days
•6. Have known allergies to any of the components used in the formulation of the interventions
•7. Have hemodynamic instability requiring use of pressors within 24 hours of randomization
•8. Have suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
•9. Have any co-morbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days
•10. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
•11. Are pregnant or breast feeding

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