Plans for assessment and collection of outcomes
sore throat, headache, fever, cough
SORE THROAT, DISEASE, ADVERSE EVENTS
Participants will be followed to assess whether they get infected with SARS-CoV-2. Participants will complete intermittent surveys via an electronic system every 7 days to assess the presence of any flu-like symptom, including sore throat, fever, headache, malaise, and cough. Note that this is part of routine surveillance for COVID-19 in health workers at the US site. Consent forms will ask for consent to access this survey information. Any positive response on the survey will trigger a nasopharyngeal, oral, and/or rectal swab to be collected to test for COVID-19 via rt-PCR. All participants, regardless of survey responses, will have serology for COVID-19 tested at 4-week intervals during the follow-up period (6 months). If a participant completes the follow-up period and does not test positive for a disease, their study participation is complete. If a participant does test positive for a disease, their disease status will be ascertained for up to 2 months or until an outcome is available through one of the following mechanisms: (1) an electronic survey if they are not admitted to the hospital, including questions about the number of days they are ill, daily fever, and other symptoms; or (2) if they are admitted to the hospital, ordinal outcomes for disease severity will be extracted from the hospital’s electronic medical records system. During the first week of follow-up, all participants will actively be asked about any adverse events; thereafter, participants will report unsolicited AEs through the electronic survey. Vaccine-related adverse events will be graded using the FDA guidance (