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

NCT ID: NCT04327804

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-25
• Study Completion Date: 2020-10-10

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.

Conditions

SARS-CoV Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Odd numbered birth year

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.

Odd/Even birth year intervention groups

Intervention Type: DIAGNOSTIC_TEST

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

Even numbered birth year

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/Even birth year intervention groups

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Odd/Even birth year intervention groups

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PATH

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

UnitedHealth Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ethan Berke

Role: PRINCIPAL_INVESTIGATOR

UnitedHealth Group Research & Development

Yuan Tu

Role: PRINCIPAL_INVESTIGATOR

OptumCare, Everett Clinic

Locations

Everett Clinic

Seattle, Washington, United States

Countries

United States

References

Coronavirus Disease 2019 (COVID-19) in the US. Centers for Disease Control and Prevention, accessed March 24, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

Reference Type: BACKGROUND

Padilla, Mariel. " 'It feels like a war zone': Doctors and Nurses Plead for Masks on Social Media". New York Times, March 19, 2020

Reference Type: BACKGROUND

Frosch, Dan, et al. "Coronavirus Testing Chaos Across America". Wall Street Journal, March 19, 2020

Reference Type: BACKGROUND

Other Identifiers

20-002

Identifier Type: -

Identifier Source: org_study_id