跳至主要内容
临床试验/NCT05607147
NCT05607147已完成不适用

Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Dental Health Care Workers

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1月26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
10
试验地点
2
主要终点
Dental Health Care Worker (DHCW) Willingness to Participate in the Study

研究概览

简要总结

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.

详细描述

10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine

排除标准

  • Previous participation

结局指标

主要结局

Dental Health Care Worker (DHCW) Willingness to Participate in the Study

时间窗: Day 1

Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study

Number of DHCW With Complete Surveys

时间窗: Through study completion (3 months)

Number of participants with complete Start-of-study, Triage and End-of-Study surveys

DHCW Test Completion

时间窗: Day 28

Percentage of DHCWs with completed SARS-CoV-2 test completed

DHCW Ease of Complying With Protocol

时间窗: Day 28

Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study

DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing

时间窗: Day 28

Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing

次要结局

  • SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive(28 days)
  • Positive Antibody Testing(28 days)
  • Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work(28 days)

研究者

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

Cecile A. Feldman, DMD

Professor

Rutgers, The State University of New Jersey

研究点 (2)

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