COVID-19 is a respiratory disease caused by the coronavirus known as (SARS)-CoV-2. SARS stands for severe acute respiratory syndrome. While some individuals infected with the virus respond with no or mild symptoms, others develop respiratory symptoms and pneumonia that requires hospitalization and can be deadly. This study will investigate the infection rate of SARS-CoV-2, how long a person that encountered the virus is able to spread the virus, and if an individual can be re-infected again. This may also help us understand which immune responses help to protect a person and need to be generated by a vaccine.
Screening Questionnaire — Once an eligible screening questionnaire is submitted and reviewed, a member of the study team will reach out for a remote consent visit which will be completed via phone and/or video chat. The study overview, training, and procedures will all be discussed at this time. If a participant continues to meet all entry criteria, they will sign an electronic consent form. Following this, participants will be sent a screening kit to self-collect samples to confirm study eligibility. Participants may receive up to $500 for completing the study. We may screen more people than we will ultimately enroll into the study.
Start of Study Visit — Participants who complete the screening period and continue to be eligible for the study will have a Start of Study or “Enrollment Visit” scheduled (about 30 minutes). During this on-site visit at the Fred Hutch, a study team member will answer any additional questions not addressed during the online consent visit and provide materials for participation in the study. A blood draw will take place at this visit.
Participant Tasks During the Study — Weeky participants will self-collect and send in a nasal swab and complete an online questionnaire. Once per month, participants will self-collect a small blood sample using a Tasso device. If a participant has cold symptoms or tests positive for COVID-19, they may be asked to provide more frequent samples. Whenever a participant experiences any symptoms — or if directed by the study team — they will self-collect using a symptom kit in addition to the weekly swab. The symptom kit includes a nasal swab, blood sample, and symptom questionnaire. There may also be an option to schedule a visiting nurse to perform an at home in-person visit which will include a blood draw.
Testing Positive for COVID-19 — If a participant tests positive for COVID-19, they will be asked to come into the clinic 4 weeks after they are notified of the result. In order to come on site, participants must be symptom free for at least 14 days and will be screened by the study team. During this on-site visit (about 30 minutes) at the Fred Hutch participants will have an additional blood draw.
Dr. Michael Boeckh is an expert in respiratory viral infections that affect individuals with healthy and weakened immune systems. His research focuses on the epidemiology, diagnostic, risk factors and immunologic control of viral infections, as well as prevention and treatment strategies.