A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 953
- 试验地点
- 52
- 主要终点
- Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples
研究概览
简要总结
The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19.
The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.
详细描述
This is a prospective study of acute immune responses to SARSCoV-2 infection.
The study will include 3 groups, as described in the table below. Groups are defined based on clinical status at enrollment, but for the purposes of data analysis, participants who experience disease progression can contribute data to other cohorts.
Participants will complete six visits over 28 days followed by a health contact at Month 2 (one month after the last scheduled visit). Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.
Study visits may include review of medical history; interviews/questionnaires; pregnancy tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash, and saliva sample collection; and optional stool sample collection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Test result indicating presence of SARS-CoV-2 virus. Sites must have results from assays that are approved as FDA-emergency use authorized or as standard-of-care by other applicable regional governing bodies. For timing of testing, please see group specific criteria below.
- •Ability and willingness to provide informed consent.
- •Willingness to have clinical research staff come to place of residence or hospital if needed.
- •Willingness to be followed for the planned duration of the study.
- •Assessment of understanding: volunteer demonstrates understanding of this study.
- •Agreement to allow access to medical records.
- •Asymptomatic participants:
- •No current symptoms.
- •No symptoms consistent with COVID-19 within 2 weeks prior to positive test according to the clinical judgement of the investigating clinician. Symptoms include, but are not limited to, fever, headache, sore throat, cough, dyspnea, rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html for the current list of symptoms consistent with COVID-
- •Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment (target time) up to 10 days prior to enrollment (upper allowable window).
- •Symptomatic (non-hospitalized) participants:
- •Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment (target time) up to 14 days prior to enrollment (upper allowable window). Symptoms of COVID-19 to be determined by the clinical judgement of the investigating clinician including-- but not limited to-- fever, headache, sore throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia. Please refer to https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html for the current list of symptoms consistent with COVID-
- •Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment (target time) up to 10 days prior to enrollment (upper allowable window).
- •Symptomatic (hospitalized) participants
- •Participant hospitalized for COVID-19 within 3 days prior to enrollment (note: there is no timeframe for either symptom onset or timing of SARS-CoV-2 PCR or antigen testing for hospitalized participants)
排除标准
- •Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent.
结局指标
主要结局
Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples
时间窗: Measured through day 28
Measured by neutralizing antibody assay (nAb)
Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples
时间窗: Measured through day 28
Measured by binding antibody multiplex assay (BAMA)
Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples
时间窗: Measured through day 28
Measured by binding antibody multiplex assay (BAMA)
Transcriptional profiles of peripheral blood leukocytes
时间窗: Measured through day 14
Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling
Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells
时间窗: Measured through day 28
Measured by flow cytometry
Concentration of serum cytokines and other soluble factors
时间窗: Measured through day 28
Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)
Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells
时间窗: Measured through day 28
Measured by flow cytometry
Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells
时间窗: Measured through day 28
Measured by flow cytometry
Response rate of SARS-CoV-2-specific B cells in peripheral blood samples
时间窗: Measured through day 14
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples
时间窗: Measured through day 28
Measured by binding antibody multiplex assay (BAMA)
Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples
时间窗: Measured through day 14
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples
时间窗: Measured through day 14
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Response rate of SARS-CoV-2-specific antibody binding in serum samples
时间窗: Measured through day 28
Measured by binding antibody multiplex assay (BAMA)
Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples
时间窗: Measured through day 28
Measured by neutralizing antibody assay (nAb)
Frequency of leukocyte populations in peripheral blood
时间窗: Measured through day 14
Measured by flow cytometry
次要结局
- Quantitation of viral RNA in nasal swabs(Measured through day 28)