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

SARS-CoV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327804
• Other study ID #: 20-002
• Status: Completed
• Start date: March 25, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: April 2022
• Source: UnitedHealth Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 10, 2020
• Est. primary completion date: August 18, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Odd/Even birth year intervention groups
The nostril used and order of testing will be different in each arm.

Locations

Country	Name	City	State
United States	Everett Clinic	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
UnitedHealth Group	Bill and Melinda Gates Foundation, Mayo Clinic, PATH

Country where clinical trial is conducted

United States, 

References & 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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 months