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

Completed

• Conditions: SARS-CoV Infection
• Interventions: Diagnostic Test: Odd/Even birth year intervention groups

• Registration Number: NCT04327804
• Lead Sponsor: UnitedHealth Group

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-03-25
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-31
• Primary Completion: 2020-08-18
• Study Completion: 2020-10-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Even numbered birth year	Odd/Even birth year intervention groups	The collection of patient samples will be different as defined by odd/even birth year. Patients born in an even numbered year will first have their left nostril swabbed by the two polyester swabs followed by their right nostril being swabbed by a foam swab.
Odd numbered birth year	Odd/Even birth year intervention groups	The collection of patient samples will be different as defined by odd/even birth year. Patients born in an odd numbered year will first have their left nostril swabbed by the foam swab followed by their right nostril being swabbed by the two polyester swabs.

Primary Outcome Measures

Name	Time	Method
Detection of SARS-CoV-2 virus	42 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Everett Clinic; 🇺🇸 Seattle, Washington, United States