Minimal risk research study: 1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus; 2. Quantifying the development and trajectory of the disease through clinic visits and blood values.
This work will serve both the Everett Clinic and broader UnitedHealth Group patient
populations as well as advance the public health emergency response to the community spread
of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many
geographies. A recent study conducted at The Everett Clinic showed that foam nasal swabs were
able to detect SARS-CoV-2 virus at comparable levels to nasopharyngeal (NP) swabs. We now
look to build off this work by comparing polyester foam swabs, which are more readily
available and mass producible, to foam nasal swabs, in their sensitivity for detecting
SARS-CoV-2 virus. We also plan to assess the viability of dry swabbing, where the swab is
stored without saline or viral transport media (VTM) at room temperature for four days, to
calculate the degradation of the viral sample.
Finally, we will collect up to 50 mL/visit of blood longitudinally from patients who have
previously tested positive for SARS-CoV-2 at visit one, two, and four weeks following their
initial COVID-10 diagnosis.The medical professional drawing the blood will determine if the
patient is at an increased risk from a blood draw due to underlying conditions such as
anemia. In these cases, the amount of blood drawn will be left to the discretion of the
medical professional but shall not surpass 10 mL per visit.These longitudinal blood samples
will help us gain a better understanding of the trajectory of COVID-19 (in terms of both
clinical symptomology and viral load) and antibody development. At each visit, nasal swabs
and blood samples will be collected, and the blood samples will be stored in a repository for
future research.
Diagnostic Test: Odd/Even birth year intervention groups
The nostril used and order of testing will be different in each arm.
Inclusion Criteria:
- Existing patient of the Everett Clinic (i.e., has previously sought care)
- Tested positive for SARS-CoV-2 virus (confirmed by RT-PCR) prior to time of enrollment
Exclusion Criteria:
- Not able to demonstrate understanding of the study
- Not able to safely travel to the clinic without endangering themselves or risking
exposing others to SARS-CoV-2
- Medical history evidencing any of the following
- Active nosebleed in the past 24 hours
- Nasal surgery in the past two weeks
- Chemotherapy treatment with low platelet and low white blood cell counts
- Acute facial trauma
- Advanced COVID-19 state that would preclude safe and feasible sample collection
Everett Clinic
Seattle, Washington, United States