EUCTR2020-003503-34-DE进行中（未招募）1 期
A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals - DZIF-10c_Infusion
niversity of Cologne0 个研究点目标入组 69 人开始时间: 2020年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
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
- •Groups 1A-1D
- •- Age 18 to 65.
- •- SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
- •- Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
- •Groups 2C-2D
- •- Age 18 to 70.
- •- SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
- •- Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or angeusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration
- •Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
- •- Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020)
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •- Known hypersensitivity to any constituent of the investigational medicinal product.
- •- Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
- •- Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
- •- HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
- •- Blood laboratory parameter abnormalities as listed below
- •- Neutrophil count =1,000 cells/µl
- •- Hemoglobin =10 g/dl
- •- Platelet count =100,000 cells/µl
- •- ALT =2.0 x ULN
- •- AST =2.0 x ULN
- •- Total bilirubin =1.5 ULN
- •- eGFR <60 ml/min/1.73m2
- •- Pregnancy or lactation.
- •- Any vaccination within 14 days prior to DZIF-10c administration.
- •- Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
- •- Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
- •- Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
- •- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within =6 months and =4 weeks of enrollment is acceptable).
- •- Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
- •- Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
- •- Legally incapacitated individuals
- •- Individuals held in an institution by legal or official order
- •- If engaging in sexual activity that could result in pregnancy, inability or unwilligness to comply with the requirements for highly effective contraception.
研究者
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