NCT05054088已完成不适用
ImmuneSense™ COVID-19 Variant Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 14
- 主要终点
- Primary Objective: Positive Percent Agreement
研究概览
简要总结
This study will assess the clinical performance of the T-Detect™ COVID test to identify an immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which changes over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must satisfy the following criteria to be enrolled in the study:
- •i. Individuals who have tested positive for SARS-CoV-2 via EUA RT-PCR testing. ii. Male and female participants of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of enrollment in the study. iii. Must be able to communicate with the investigator, understand, and comply with the requirements of the study. iv. Must be able to provide estimated date of symptom onset. v. Must be available for specimen collection greater than 14 days (i.e., 15 days inclusive onward) and less than 107 days (i.e., 106 days inclusive or less) after first exhibiting symptoms of confirmed SARS-CoV-2 infection.
排除标准
- •The presence of any of the following will exclude a participant from enrollment:
- •Individuals who did not test positive for SARS-CoV-2 on EUA RT-PCR.
- •Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state.
- •Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study.
- •Exposure to a SARS-CoV-2 investigational drug (new chemical entity) within 60 days prior to enrollment at the discretion of the Sponsor.
- •Receipt of immunosuppressive medications, such as, but not limited to, recent moderate- or high-dose systemic steroids or immunomodulators within 1 month prior to enrollment at the discretion of the Sponsor.
- •Treatment with immunosuppressants/ immunomodulators that do not impact T cells or B cells may be allowed at the discretion of the Sponsor.
- •Steroid formulations including low-dose oral steroids (≤ 10 mg prednisone equivalents per day), inhaled steroids, or topical steroids are not considered exclusionary. Doses >10 and <20 mg prednisone equivalents per day, must receive Sponsor approval.
结局指标
主要结局
Primary Objective: Positive Percent Agreement
时间窗: Baseline
To determine the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing in populations having multiple circulating SARS-CoV-2 variant strains. The primary endpoint is the positive percent agreement (PPA) of the T-Detect™ COVID test with SARS-CoV-2 RT-PCR testing.
次要结局
未报告次要终点
研究者
研究点 (14)
Loading locations...
相似试验
撤回
不适用
ImmuneSense™ COVID-19 Cross-Reactivity StudyCoronavirus DiseaseSARS-CoV-2 InfectionNCT05112874Adaptive Biotechnologies
Unknown
4 期
Immunogenicity Study of the Covid-19 (Recombinante) Vaccine With a 4 or 8 Week Interval Between the First Doses.COVID-19NCT05157178The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)1,264
Unknown
不适用
Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19SARS-CoV 2COVID-19NCT04405492Assistance Publique - Hôpitaux de Paris1,210
已完成
不适用
ImmuneRACE - Immune Response Action to COVID-19 EventsCovid19NCT04494893Adaptive Biotechnologies808
Unknown
不适用
COVID-19 Thales Thermography Triage : Thermal Camera Feasibility StudyPyrexiaCOVIDNCT04397380NHS Greater Clyde and Glasgow100