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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327804
Recruitment Status : Completed
First Posted : March 31, 2020
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
PATH
Mayo Clinic
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
UnitedHealth Group

Study Description
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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.

Condition or disease Intervention/treatment
SARS-CoV Infection Diagnostic Test: Odd/Even birth year intervention groups

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 Design
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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research
Actual Study Start Date : March 25, 2020
Actual Primary Completion Date : August 18, 2020
Actual Study Completion Date : October 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.
 Diagnostic Test: Odd/Even birth year intervention groups
The nostril used and order of testing will be different in each arm.


Outcome Measures
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Primary Outcome Measures :
  1. Detection of SARS-CoV-2 virus [ Time Frame: 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 :
  1. Trajectory of COVID-19 and antibody development [ Time Frame: 2 months ]
    Longitudinal blood samples from SARS-CoV-2 patients to gain a better understanding of the trajectory of COVID-19 and antibody development


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.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327804


Locations
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United States, Washington
Everett Clinic
Seattle, Washington, United States, 98133
Sponsors and Collaborators
UnitedHealth Group
PATH
Mayo Clinic
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Ethan Berke UnitedHealth Group Research & Development
Principal Investigator: Yuan Tu OptumCare, Everett Clinic
More Information
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Publications:
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
Padilla, Mariel. " 'It feels like a war zone': Doctors and Nurses Plead for Masks on Social Media". New York Times, March 19, 2020
Frosch, Dan, et al. "Coronavirus Testing Chaos Across America". Wall Street Journal, March 19, 2020

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Responsible Party: UnitedHealth Group
ClinicalTrials.gov Identifier: NCT04327804    
Other Study ID Numbers: 20-002
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases