A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

UnitedHealth Group139 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

139

Conditions

SARS-CoV Infection

Interventions

Odd/Even birth year intervention groupsDIAGNOSTIC_TEST

The nostril used and order of testing will be different in each arm.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Everett Clinic

Seattle, Washington, United States

Outcomes

Primary Outcomes

Detection of SARS-CoV-2 virus

Measure the agreement between the detection of SARS-CoV-2 virus using a foam nasal swab tested directly after collection, a polyester nasal swab tested directly after testing, and a polyester nasal swab stored at room temperature for four days without saline or VTM before being tested.

Time frame: 42 days

Secondary Outcomes

Trajectory of COVID-19 and antibody development

Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development

Time frame: 2 months

Data from ClinicalTrials.gov

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