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Clinical Trials/ISRCTN71579301
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.

Registry
who.int
Start Date
April 26, 2022
End Date
June 30, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
eyden Laboratories B.V.

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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