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

NCT04327804 | Completed

• 1 other identifier: 20-002
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

Minimal risk research study:

1. 1.Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus;
2. 2.Quantifying the development and trajectory of the disease through clinic visits and blood values.

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  42 days

Secondary Outcomes (1)

• Trajectory of COVID-19 and antibody development

  2 months

Study Arms (2)

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.

Diagnostic Test: Odd/Even birth year intervention groups

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.

Diagnostic Test: Odd/Even birth year intervention groups

Interventions

Odd/Even birth year intervention groups DIAGNOSTIC_TEST

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

Even numbered birth year; Odd numbered birth year

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UnitedHealth Group: lead
• PATH: collaborator
• Mayo Clinic: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Everett Clinic

Seattle, Washington, 98133, United States

Location

Related Publications (3)

• 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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients will return at the following times to complete the same battery of sample collection: * 7-9 days after initially testing positive; * 14-18 days after initially testing positive; * 28-42 days after initially testing positive. Additional visits, during which additional samples could be collected may occur after 42 days if agreeable to the participants and desired by the study investigators.

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Ethan Berke

  UnitedHealth Group Research & Development

  PRINCIPAL INVESTIGATOR

• Yuan Tu

  OptumCare, Everett Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: March 25, 2020
• Primary Completion: August 18, 2020
• Study Completion: October 10, 2020
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 months
• Access Criteria: 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.

Locations

US (1)