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临床试验/NCT04327804
NCT04327804已完成不适用

A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

UnitedHealth Group1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2020年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Detection of SARS-CoV-2 virus

研究概览

简要总结

Minimal risk research study:

  1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus;
  2. Quantifying the development and trajectory of the disease through clinic visits and blood values.

详细描述

This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. A recent study conducted at The Everett Clinic showed that foam nasal swabs were able to detect SARS-CoV-2 virus at comparable levels to nasopharyngeal (NP) swabs. We now look to build off this work by comparing polyester foam swabs, which are more readily available and mass producible, to foam nasal swabs, in their sensitivity for detecting SARS-CoV-2 virus. We also plan to assess the viability of dry swabbing, where the swab is stored without saline or viral transport media (VTM) at room temperature for four days, to calculate the degradation of the viral sample.

Finally, we will collect up to 50 mL/visit of blood longitudinally from patients who have previously tested positive for SARS-CoV-2 at visit one, two, and four weeks following their initial COVID-10 diagnosis.The medical professional drawing the blood will determine if the patient is at an increased risk from a blood draw due to underlying conditions such as anemia. In these cases, the amount of blood drawn will be left to the discretion of the medical professional but shall not surpass 10 mL per visit.These longitudinal blood samples will help us gain a better understanding of the trajectory of COVID-19 (in terms of both clinical symptomology and viral load) and antibody development. At each visit, nasal swabs and blood samples will be collected, and the blood samples will be stored in a repository for future research.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Existing patient of the Everett Clinic (i.e., has previously sought care)
  • Tested positive for SARS-CoV-2 virus (confirmed by RT-PCR) prior to time of enrollment

排除标准

  • Not able to demonstrate understanding of the study
  • Not able to safely travel to the clinic without endangering themselves or risking exposing others to SARS-CoV-2
  • Medical history evidencing any of the following
  • Active nosebleed in the past 24 hours
  • Nasal surgery in the past two weeks
  • Chemotherapy treatment with low platelet and low white blood cell counts
  • Acute facial trauma
  • Advanced COVID-19 state that would preclude safe and feasible sample collection

结局指标

主要结局

Detection of SARS-CoV-2 virus

时间窗: 42 days

Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested.

次要结局

  • Trajectory of COVID-19 and antibody development(2 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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