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临床试验/NCT04555109
NCT04555109进行中(未招募)不适用

Convalescent Plasma for COVID-19 Research (CONCOR) Donor Study

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Seroprevalence and duration of protective immunity

研究概览

简要总结

Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, natural history study of plasma donors recovered from COVID-19. CONCOR-Donor study will address immune response, duration of protective immunity, and clinical factors and host genetics contributing to the variability of immune response. We will also study long-term outcomes from COVID-19 infection. Results from the study will help define therapeutic strategies for COVID-19.

详细描述

The outbreak caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) led to the global pandemic. There are currently no proven treatments for coronavirus disease (COVID-19), however, convalescent plasma has emerged as a potential therapeutic to prevent clinical deterioration. Convalescent plasma was successfully used for other infections, in small numbers, but there is limited evidence for the efficacy of administering specific, neutralizing antibodies by transfusion of convalescent plasma. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.

As trials are underway to determine efficacy of using convalescent plasma, we will use this unique opportunity to conduct a national longitudinal cohort study of 1000 persons recovered from COVID-19 and volunteer to donate convalescent plasma. Our aims are to:1) determine if the variability of titers of viral neutralizing antibody and ELISA antibody are associated with clinical and demographic factors; 2) determine duration of protective immunity in recovered persons over 1 year and if modified by clinical and demographic factors; 3) determine genetic risk predictors of the antibody response, and 4) create a biorepository available to researchers from across Canada. Based on the World Health Organization (WHO) Coordinated Global Research Map, this project addresses the priority of the natural history of COVID-19 and clinical characterization of antibody response in the convalescent phase and beyond.

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
17 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recovered from COVID-19 infection
  • Have a positive PCR or serology or a positive household contact
  • Signed informed consent form
  • Provide blood sample
  • Ability to complete a questionnaire

排除标准

  • 未提供

结局指标

主要结局

Seroprevalence and duration of protective immunity

时间窗: 12 months

Determine if the titers of SARS-CoV-2-specific neutralizing antibody and serum ELISA antibodies, are correlated with clinical and demographic factors such as age, sex, comorbidities, geographic region, and severity of prior COVID-19 symptoms, during the convalescent phase.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rulan Parekh

Staff Physician, Associate Chief Clinical Research

The Hospital for Sick Children

研究点 (1)

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