EUCTR2020-004448-27-DE进行中（未招募）1 期
A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals - DZIF-10c_Inhalation
niversity of Cologne0 个研究点目标入组 96 人开始时间: 2020年11月18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
- 96
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-1C
- •-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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
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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