Covid19NCT04720794
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
A study testing Lucira COVID-19 All-In-One test kit in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Lucira Health Inc at 1 site in United States.
Trial summary
This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, SARS (Severe Acute Respiratory Syndrome), Corona Virus Infection
- What is being tested?
- Lucira COVID-19 All-In-One test kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 20 Oct 2020
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75
- Must be able to read and write in English or Spanish
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
- Must be one of the following:
- Currently experiencing a Fever of 100﮲ Fahrenheit and above or self-reports having fever within the past 48 hours, and experiencing at least one (1) additional associated CDC COVID-19 symptom:
- Cough
Show all 17Show fewer
- Shortness of breath or difficulty breathing
- Fatigue
- Muscle or body aches
- Headache
- New loss of taste or smell
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
- Previously tested positive for COVID-19 in past 14 days, and experiencing at least one (1) additional associated CDC COVID-19 symptom
- Currently experiencing at least three (3) additional associated CDC COVID-19 symptoms so long as at least at least one (1) symptom is either: cough, shortness of breath, and/or new loss of taste or smell.
Who cannot join
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates for standard of care testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Neeraj Kochhar Family Medicine
Los Gatos, California, 95032
About this study
Official title: A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay
This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs.
The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit.
Read more
This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff.
A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI).
Following the Lucira COVID-19 All-In-One Test Kit self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.
Read the detailed description
The study is a prospective, single site study with community-based sampling in high COVID-19 prevalence communities in California. The Investigational device will be tested on-site and the reference samples will be sent to one (1) reference laboratory in the U.S. Testing in the reference laboratory will be performed by trained laboratory personnel. This study, to be performed with medical staff on site, and will include nasal swabs self-collected by study subjects per the QRI.
Community based sampling will be conducted only by trained medical study staff. Study staff will bring all study materials-the Lucira investigational device as well as the reference swab collection kit-to all subjects enrolled in the study. This mobile, outdoor, community-based sampling method will ensure that COVID-symptomatic persons with fever do not travel from their homes, thus risking exposure to others. All medical staff participating in the study will be under the oversight of the study Principal Investigators and wear appropriate PPE during community visits.
A qualified research person will be designated as the Investigator at each site, with the responsibility for oversight of the study in accordance with Good Clinical Practice (GCP) and regulatory requirements. The protocol and subject informed consent will be reviewed by an Institutional Review Board (IRB) and written IRB approval will be issued prior to enrollment of subjects into the study at that site.
A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. Subject demographics including age, sex, race, and ethnicity, will also be collected at this time.
All subjects will be observed during the swabbing collection by the HCP and HCP will document collection details and any collection issues. The HCP will confirm the Lucira COVID-19 Test Kit is running and will interpret the test results once completed. Nasal swabs obtained from self-collection will be discarded after it has been used for testing.
Following the Lucira COVID-19 Test Kit collection will be a collection for reference method testing. A reference swab should not be collected until the Lucira Test Kit is running. The nasal swab reference swab shall be collected in the same manner as the initial collection, prepared in Transport Medium and sent to the Sutter Shared Laboratory.
To evaluate performance, all reference samples collected will be tested using EUA-cleared molecular method:
- Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay *
Reference testing will characterize specimens as negative or positive for SARS-CoV-2. Therefore, sensitivity and specificity of the Lucira COVID-19 Test will be calculated by comparison with the reference methods.
Additional testing on remaining remnant aliquots may be performed to investigate any discrepant and discordant results as needed, and samples may undergo additional testing by other EUA-cleared molecular methods. The Roche Cobas 6800 SARS-CoV-2 assay will be used for discrepant testing.
If subject consents to storage and future testing of samples, any extra remnants at the end of the study will be returned to the Sponsor for storage.
- Being tested
- Lucira COVID-19 All-In-One test kit
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucira COVID-19 All-In-One test kitDevice
The Lucira COVID-19 All-In-One Test Kit is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in nasal swab samples. This test is a single-use test kit that determines whether there is active shedding of the virus which causes COVID-19. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.
Positive results are indicative of active infection with SARS-CoV-2. Persons who test positive should self-isolate and seek care from their healthcare provider.
Negative results do not preclude SARS-CoV-2 infection. Persons who continue to experience COVID-like symptoms should seek follow up care from their healthcare provider
| Study group | Role | What they receive |
|---|---|---|
| Subject Self-Collection and Specimen Testing | Other | Subjects will be provided with the Lucira COVID-19 Test Kit and collect one (1) nasal swab according to the QRI and test the sample on the Lucira COVID-19 All-In-One Test. HCP will observe subject during this process and document any observations and deviations from the QRI. Receives: Device: Lucira COVID-19 All-In-One test kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Prevalence Rate / Expected Values counts
Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age
Measured: 3 months
COVID-19 Prevalence Rate / Expected Values percentages
Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age
Measured: 3 Months
Secondary outcomes (3)
Collection Performance/ Incidence Rate counts
Study observations will be summarized by counts:
- Self-Collection, Self-tested
- User Experience
Measured: 3 Months
Collection Performance/ Incidence Rate percentages
Study observations will be summarized by percentages:
- Self-Collection, Self-tested
- User Experience
Measured: 3 Months
Sensitivity and specificity
Sensitivity and specificity along with their associated 2-sided Wilson Score 95% Confidence Intervals will be estimated for SARS-CoV-2, on the Lucira COVID-19 All-In-One Test in comparison to the reference test
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Sep 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucira Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neeraj Kochhar, MD, Principal investigator, Neeraj Kochhar Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720794
- Sponsor's protocol ID
- 07A-CLI-006
- Status last verified
- Jan 2021
- First submitted
- 13 Oct 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay
- ClinicalTrials.gov ID
- NCT04720794
- Acronym / sponsor ID
- 07A-CLI-006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Lucira Health IncIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 22 Jan 2021 (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.
This Lucira COVID-19 All-In-One Test Kit performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay. The results of this study will be used to demonstrate the Lucira COVID-19 'swab to result in 30 minutes' test kit is similar in performance to known high sensitivity best-in-class molecular assays performed in high complexity labs.
The results of this study will be combined with other studies the Sponsor has underway and will support a FDA Emergency Use Authorization (EUA) of the Lucira COVID-19 All-In-One Test Kit.
This performance study will include nasal swabs self-collected by study subjects at community-based locations with trained medical staff.
A subject's participation in this study will consist of one study visit and one collection event. The subject self-collects a nasal swab sample according to Lucira COVID-19 Test Kit instructions and runs test according to Quick Reference Instructions (QRI).
Following the Lucira COVID-19 All-In-One Test Kit self-collection will be an additional swab collection for reference method testing. One (1) additional NS specimen will be collected either by the health care professional or self-collection, prepared in Transport Medium and sent to a reference laboratory.
Detailed description
The study is a prospective, single site study with community-based sampling in high COVID-19 prevalence communities in California. The Investigational device will be tested on-site and the reference samples will be sent to one (1) reference laboratory in the U.S. Testing in the reference laboratory will be performed by trained laboratory personnel. This study, to be performed with medical staff on site, and will include nasal swabs self-collected by study subjects per the QRI.
Community based sampling will be conducted only by trained medical study staff. Study staff will bring all study materials-the Lucira investigational device as well as the reference swab collection kit-to all subjects enrolled in the study. This mobile, outdoor, community-based sampling method will ensure that COVID-symptomatic persons with fever do not travel from their homes, thus risking exposure to others. All medical staff participating in the study will be under the oversight of the study Principal Investigators and wear appropriate PPE during community visits.
A qualified research person will be designated as the Investigator at each site, with the responsibility for oversight of the study in accordance with Good Clinical Practice (GCP) and regulatory requirements. The protocol and subject informed consent will be reviewed by an Institutional Review Board (IRB) and written IRB approval will be issued prior to enrollment of subjects into the study at that site.
A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. Subject demographics including age, sex, race, and ethnicity, will also be collected at this time.
All subjects will be observed during the swabbing collection by the HCP and HCP will document collection details and any collection issues. The HCP will confirm the Lucira COVID-19 Test Kit is running and will interpret the test results once completed. Nasal swabs obtained from self-collection will be discarded after it has been used for testing.
Following the Lucira COVID-19 Test Kit collection will be a collection for reference method testing. A reference swab should not be collected until the Lucira Test Kit is running. The nasal swab reference swab shall be collected in the same manner as the initial collection, prepared in Transport Medium and sent to the Sutter Shared Laboratory.
To evaluate performance, all reference samples collected will be tested using EUA-cleared molecular method:
- Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay *
Reference testing will characterize specimens as negative or positive for SARS-CoV-2. Therefore, sensitivity and specificity of the Lucira COVID-19 Test will be calculated by comparison with the reference methods.
Additional testing on remaining remnant aliquots may be performed to investigate any discrepant and discordant results as needed, and samples may undergo additional testing by other EUA-cleared molecular methods. The Roche Cobas 6800 SARS-CoV-2 assay will be used for discrepant testing.
If subject consents to storage and future testing of samples, any extra remnants at the end of the study will be returned to the Sponsor for storage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject Self-Collection and Specimen Testing | Other | Device: Lucira COVID-19 All-In-One test kitSubjects will be provided with the Lucira COVID-19 Test Kit and collect one (1) nasal swab according to the QRI and test the sample on the Lucira COVID-19 All-In-One Test. HCP will observe subject during this process and document any observations and deviations from the QRI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ages 18-75
- Must be able to read and write in English or Spanish
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
- Must be one of the following:
Key exclusion criteria (2 listed)
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates for standard of care testing
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 |
|---|---|---|
| Lucira COVID-19 All-In-One test kitThe Lucira COVID-19 All-In-One Test Kit is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in nasal swab samples. This test is a single-use test kit that determines whether there is active shedding of the virus which causes COVID-19. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA. Positive results are indicative of active infection with SARS-CoV-2. Persons who test positive should self-isolate and seek care from their healthcare provider. Negative results do not preclude SARS-CoV-2 infection. Persons who continue to experience COVID-like symptoms should seek follow up care from their healthcare provider | Device | Subject Self-Collection and Specimen Testing |
Primary outcome
COVID-19 Prevalence Rate / Expected Values counts
Time frame: 3 months
Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age
COVID-19 Prevalence Rate / Expected Values percentages
Time frame: 3 Months
Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age
3 secondary outcomes
Collection Performance/ Incidence Rate counts
Time frame: 3 Months
Collection Performance/ Incidence Rate percentages
Time frame: 3 Months
Sensitivity and specificity
Time frame: 3 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 26 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Neeraj Kochhar, MD principal investigator
Neeraj Kochhar Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucira COVID-19 All-In-One test kit in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Lucira Health Inc 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 17 inclusion and 2 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 26 Jan 2021. 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?
COVID-19 Prevalence Rate / Expected Values counts (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2021.