ACTRN12621001039875已完成未知
The Western Australian COVID-19 Immunity Collaborative (WACIC) Biobank: a prospective bio repository of specimens and clinical data to enable research and development of diagnostic assays relevant to SARS-CoV-2 immunity.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 682
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- Years 至 o limit（—）
- 性别
- All
入选标准
- •Cohort 1: COVID-19 Positive Cases
- •Adult Inclusion Criteria:
- •more than or equal to 18 years of age
- •Have had a confirmed case of COVID-19 as defined by at least one PCR-positive nasopharyngeal and/or throat swab
- •Child Inclusion Criteria:
- •less than 18 years of age
- •Have had a confirmed case of COVID-19 as defined by at least one PCR-positive nasopharyngeal and/or throat swab, or be suspected to have COVID-19 based on the presence of clinical symptoms and referred for a nasopharyngeal and/or throat swab or other diagnostic test for SARS-CoV-2 infection
- •Parent/guardian's consent to participate
- •Cohort 2: Close Contacts
- •Adult Inclusion Criteria:
- •more than or equal to 18 years of age
- •A close contact of a COVID-19 positive case, as defined by current Public Health criteria, who have either not been tested for COVID-19, or who received a negative COVID-19 test result (i.e. non-infected by PCR).
- •Child Inclusion criteria
- •less than 18 years of age
- •A close contact of a COVID-19 positive case, as defined by current Public Health criteria, who have either not been tested for COVID-19, or who received a negative COVID-19 test result (i.e. non-infected by PCR).
- •Cohort 3: Immunised
- •more than or equal to 18 years of age
- •Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine
- •less than 18 years of age
- •Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine
- •Cohort 4: Healthy Controls
- •Adult Inclusion Criteria:
- •more than or equal to 18 years of age
- •Not known to have been exposed to SARS-CoV-2
- •Cohort 5: Immunocompromised and Immunised
- •Adult Inclusion Criteria:
- •more than or equal to 18 years of age
- •People who are immunocompromised due to their underlying disease, medical treatment or other factors, including but not limited to:
- •oPeople within 12 months of stem cell transplant
- •oRenal transplant recipients and end stage kidney disease patients on dialysis
- •oMelanoma and Lung cancer patients on immune checkpoint inhibitors.
- •oBreast cancer patients on Immunotherapy
- •oPeople with autoimmune conditions including rheumatoid arthritis on antimetabolite medication and multiple sclerosis on B-cell suppressive medication
- •oHIV infection
- •oOther groups of people identified as potentially immunocompromised as described in the Australian Immunisation Handbook
- •Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine
排除标准
- •Cohort 1: COVID-19 Positive Cases
- •Individuals who are not capable of providing their own informed consent
- •Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
- •Clinician’s assessment that study requirements is detrimental to the child.
- •Cohort 2: Close Contacts
- •Adult Exclusion Criteria:
- •Individuals who are not capable of providing their own informed consent
- •Anyone who has received a positive COVID-19 PCR result or serology result (these individuals will be recruited under the COVID-19 positive cohort).
- •Child Exclusion Criteria:
- •Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
- •Anyone who has received a positive COVID-19 PCR result or serology result (these individuals will be recruited under the COVID-19 positive cohort).
- •Clinician’s assessment that study requirements is detrimental to the child.
- •Cohort 3: Immunised
- •Individuals who are not capable of providing their own informed consent
- •Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
- •Clinician’s assessment that study requirements is detrimental to the child.
- •Cohort 4: Healthy Controls
- •Individuals who are not capable of providing their own informed consent
- •Cohort 5: Immunocompromised and Immunised
- •Individuals who are not capable of providing their own informed consent
- •Patients for whom, in the opinion of their treating consultant, donation of blood samples for this study would pose a risk of harm or side effects greater than the expected minor side effects from venepuncture (e.g. local discomfort and bruising).
研究者
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