ISRCTN71579301
Completed
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 sites104 target enrollmentApril 26, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Viral respiratory infections in adults.
- Sponsor
- eyden Laboratories B.V.
- Enrollment
- 104
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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\);
Outcomes
Primary Outcomes
Not specified
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