ACTRN12620001249943招募中1 期
Intravenous immunoglobulin rich in neutralising antibodies to SARS-CoV-2 as a passiveimmunity modality in healthy individuals : an open label, active control Phase 1/2 Study to investigate the safety profile and to characterise the pharmacokinetics of COVID-19 convalescent plasma and hyperimmune intravenous immunoglobulin G specific to SARS-CoV-2.
Aegros Ltd.0 个研究点目标入组 30 人开始时间: 2020年11月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adult participants 18 years and over at the time of consent
- •2. Healthy adults or adults with pre-existing medical conditions who are in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months before enrolment
- •3. Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
- •4. Willing and able to adhere to follow-up schedule
- •5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- •Has a negative pregnancy test at Screening and on Day 1.
- •Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1.
- •Has agreed to continue adequate contraception throughout the study period Day 1 to Day 42.
- •Is not currently breastfeeding.
- •Adequate female contraception is defined as consistent and correct use of a Therapeutic Goods Administration (TGA) approved contraceptive method in
- •accordance with the product label. For example:
- •Abstinence, where abstinence is the preferred and usual lifestyle of the participant
- •Double barrier method (a condom and one other method of adequate contraception)
- •Hormonal methods associated with inhibition of ovulation.
- •Acceptable hormonal methods include: oral contraceptives, contraceptive medication patch, contraceptive medication injection, estrogen / progestin vaginal ring, or contraceptive medication implant.
- •Intrauterine device
- •Sterilisation of a female participant’s monogamous male partner (with medical assessment of surgical success) prior to entry into the study
- •Note: periodic abstinence (e.g. calendar, ovulation, symptom-thermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- •6. Male participants with female partners planning pregnancy should follow adequate contraception for the entire study period Day 1 to Day 42.
排除标准
- •1.Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a body temperature greater than or equal to 37.5°C. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- •2.Concurrent, diagnosed, viral or bacterial infections that in the investigator’s opinion should exclude their participation.
- •3.Current infection with SARS-CoV-2 (positive result with either rapid antigen or PCR test)
- •4.Known infection with SARS-CoV-2 and resolution of symptoms within the last 60 days.
- •5.Vaccination against COVID-19 within the last 60 days.
- •6.Anti-SARS-CoV-2 anti-spike antibody level greater than or equal to 5000 AU per the Abbott AdviseDx SARS CoV-2 IgG II assay (or equivalent)
- •7.Anti-SARS-CoV-2 anti-nucleocapsid level above positive cut off level of 50 AU per the Abbott ARCHITECT SARS CoV-2 IgG assay (or equivalent).
- •8.Planned simultaneous participation in another interventional study to prevent or treat COVID-19.
- •9.Planned administration of any vaccine, including any type of COVID-19 vaccine, is not permitted until completion of the Week 6 (day 42+/-3) visit.
- •10.Proven hypersensitivity or allergic reaction to blood products or immunoglobulins or sodium citrate
- •11.Selective IgA deficiency (less than 70 mg/dL)
- •12.Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids greater than or equal to 20 mg/day of prednisone equivalent).
- •13.Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections
- •14.Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
- •15.Has participated in an interventional clinical study within 28 days prior to the day of enrolment.
- •16.Pregnant or breastfeeding.
- •17.Inability to adhere to follow up schedule
- •18.Not a suitable volunteer in the opinion of the investigator
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