EUCTR2021-004035-88-IT进行中（未招募）1 期
A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov) - AntiCov
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 400 人开始时间: 2021年8月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •1.Signed Informed Consent Form
- •2. Men or non-pregnant women =12 years of age at the time of randomization
- •3. Agree to the collection of nasopharyngeal swabs
- •4. Patients currently not hospitalized
- •5. Have one or more mild or moderate COVID-19 symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath
- •6. Must have sample collection for first positive SARS-CoV-2 viral infection
- •7. High risk for severe COVID-19 disease defined as the presence of one or more of the following conditions: age=65 years, BMI=30 kg/m2, chronic kidney disease, chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension, diabetes, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), immunocompromised state, liver disease, stroke or cerebrovascular disease.
- •Are the trial subjects under 18? yes
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Have SpO2 =92% on room air at sea level or PaO2/FiO2 <300
- •2. Respiratory rate =30 per minute
- •3. Heart rate =125 per minute
- •4. Hospitalized for COVID-19 disease
- •5. Respiratory failure secondary to COVID-19 disease
- •6. Have known allergies to any of the components used in the formulation of the interventions
- •7. Have hemodynamic instability
- •8. 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 comorbidity 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. Have a history of a positive SARS-CoV-2 serology test
- •12. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing (Anti-COVID-19 vaccines are allowed)
- •13. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
- •14. Have a history of convalescent COVID-19 plasma treatment
- •15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
- •16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •17. Are pregnant or breast feeding.
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