ISRCTN71579301已完成未知
Observational study to investigate incidence and aetiology of viral respiratory infections in young adults who are sharing housing with other young adults during the peak 2021/2022 common cold season in the Netherlands
eyden Laboratories B.V.0 个研究点目标入组 104 人开始时间: 2022年4月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Male or female, 18-40 years of age (inclusive) at screening;
- •2. Living in a shared household that include at least 4 adults within the age range of 18-40 years old, of whom at least 2 will be participating in the study
- •3. Sharing common spaces in the house, such as kitchen, living room, bathroom, etc. with household members mentioned above
- •4. Agreeing to sign the study informed consent form prior to any study-related procedure indicating that he or she understands the purpose, procedures and potential risks, and is willing to participate in the study;
- •5. Willing and able to complete the study procedures;
- •6. Has a primary care physician at the time of enrolment.
排除标准
- •1. Received or plans to receive the 2021/22 seasonal flu vaccine during the study period;
- •2. Received COVID-19 vaccines 14 days or less before screening or during the study;
- •3. Is not protected against SARS-CoV-2 infection during the whole study period. In line with the National Institute for Public Health and Environment (RIVM in Dutch) guidance, a person is considered to be protected against COVID-19 if one or more of the following applies:
- •* it is more than 14 days since having received a second COVID-19 vaccination with the AstraZeneca, Pfizer or Moderna vaccine;
- •* it is more than 28 days since having received one COVID-19 vaccination with the Janssen vaccine;
- •* it is more than 14 days since having received one vaccination with any of the COVID19 vaccines used in the Netherlands, in combination with having had a previous (PCR proven) COVID-19 infection;
- •* a (PCR proven) COVID-19 infection within the past 6 months provided the end of these 6 months is after the ending of the study.
- •4. Plans to move homes during the study;
- •5. History of chronic rhinitis or (expected) active allergic rhinitis during the envisioned study period;
- •6. Women in the third trimester of pregnancy during the study period (Jan-May 2022);
- •7. Immunocompromised or having received clinically significant immunosuppressive medication or other immunomodulating agents (including investigational drugs) in the 3 weeks prior to the first study day and during the study or 5 half-lives of the drug;
- •8. Clinically significant nasal abnormalities that might interfere with nasal sampling procedures;
- •9. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening, or donation of plasma within 14 days of screening or intention to donate blood or blood products during the study;
- •10. Any known factor, condition, or disease that might interfere with compliance, study conduct or interpretation of the results, as deemed by the investigator.
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