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.

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

All patients who previously tested positive for SARS-CoV-2 virus at the Everett Clinic within the last month will be contacted and evaluated based on the inclusion/exclusion criteria.

Four data sources will be recorded for each patient who consents to participate in the study:

• Electronic medical record (EMR);
• Results of testing from the foam and polyester nasal swab samples;
• Results of any blood testing performed on the blood samples;
• Responses to a set of standard questions posed to each participant.

2 months

The data collected due to this study will be extracted from the medical record and stored for additional research analysis to demonstrate equivalence between location in the two nasal swabs. Blood samples will be delivered to PATH and the Mayo Clinic for storage and analysis. Patients may not have access to these samples or the blood features derived from them after sample collection. Data will be shared between the participating clinics, UHG and collaborating partners performing the analysis of the samples and returning results.