SARS-CoV InfectionNCT04327804
A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research
An observational study of SARS-CoV Infection, run by UnitedHealth Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- Odd/Even birth year intervention groups
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Minimal risk research study:
- Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus;
- Quantifying the development and trajectory of the disease through clinic visits and blood values.
Read the 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
- Being tested
- Odd/Even birth year intervention groups
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odd/Even birth year intervention groupsDiagnostic test
The nostril used and order of testing will be different in each arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Odd/Even birth year intervention groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days
Secondary outcomes (1)
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start25 Mar 2020
- Primary completion18 Aug 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH, Mayo Clinic, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Ethan Berke, Principal investigator, UnitedHealth Group Research & DevelopmentYuan Tu, Principal investigator, OptumCare, Everett Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327804
- Sponsor's protocol ID
- 20-002
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research
- ClinicalTrials.gov ID
- NCT04327804
- Acronym / sponsor ID
- 20-002
- Conditions
- SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Collaborators
- PATH, Mayo Clinic, Bill and Melinda Gates Foundation
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimal risk research study:
- Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus;
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odd numbered birth year | – | Diagnostic Test: Odd/Even birth year intervention groupsThe 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. |
| Even numbered birth year | – | Diagnostic Test: Odd/Even birth year intervention groupsThe 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Advanced COVID-19 state that would preclude safe and feasible sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Odd/Even birth year intervention groupsThe nostril used and order of testing will be different in each arm. | Diagnostic test | Even numbered birth year, Odd numbered birth year |
Primary outcome
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.
1 secondary outcome
Trajectory of COVID-19 and antibody development
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- BackgroundCoronavirus 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
- BackgroundPadilla, Mariel. " 'It feels like a war zone': Doctors and Nurses Plead for Masks on Social Media". New York Times, March 19, 2020
- BackgroundFrosch, Dan, et al. "Coronavirus Testing Chaos Across America". Wall Street Journal, March 19, 2020
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Berke principal investigator
UnitedHealth Group Research & Development
Yuan Tu principal investigator
OptumCare, Everett Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection, run by UnitedHealth Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of SARS-CoV-2 virus (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327804, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.