NL-OMON52306已完成不适用
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 2021/22 common cold season in the Netherlands. - Viral respiratory infections in adults
eyden Labs BV0 个研究点目标入组 104 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- 年龄范围
- 18 至 64（—）
入选标准
- •Inclusion criteria (applicable to all participants in the study, including
- •housemates who only participate in contact visits)
- •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
- •Exclusion criteria (applicable to participants who will take part in the whole
- •study, but not to those who only take part in contact visits)
- •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 (COVID-19 vaccine boosters during the study are allowed);
- •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
- •COVID-19 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
- •7. Immunocompromised or having received clinically significant
- •immunosuppressive medication or other immunomodulating agents (including
- •investigational drugs and not including vaccines except for the 2021/22
- •seasonal influenza vaccine) 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.
研究者
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