Covid19NCT04720235
A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit
A study testing Lucira COVID-19 All-In-One test kit in people with Covid19 and Corona Virus Infection, run by Lucira Health Inc at 1 site in United States.
Trial summary
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, 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
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 30 Mar 2021
- 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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ages 14-75
- Must be able to read and write in English
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
Who cannot join
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates in past 12 hours
- Currently experiencing any of the CDC COVID-19 symptoms:
- Fever
- Cough
- Shortness of breath or difficulty breathing
Show all 14Show fewer
- Fatigue
- New loss of taste or smell
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Nausea or vomiting
- Diarrhea
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 Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay Among Asymptomatic Subjects
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.
Read the detailed description
This Lucira COVID-19 All-In-One Test Kit recently received FDA Emergency Use Authorization (EUA) for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. The basis for this FDA EUA authorization was Lucira Health's first Community Testing study (07A-CLI-006) conducted among individuals suspected of COVID-19. This follow on 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 among asymptomatic individuals. The results of this study will be used to support an expanded indication for the Lucira COVID-19 All-In-One Test Kit among asymptomatic individuals.
This performance study will include the collection of subject demographics and nasal swabs self-collected by study subjects at community-based locations with trained medical staff oversight.
After determining subject eligibility and following the completion of the informed consent process, each subject will receive a unique study identification number.
A subject's participation in this study will consist of one study visit with one collection event. The subject self-collects a nasal swab sample and runs the Lucira COVID-19 All-In-One Test Kit according to the FDA EUA authorized package insert instructions.
Subject will be observed during the swabbing collection by the study staff and study staff will document collection details and any collection issues. Nasal swabs obtained from self-collection will be discarded after having been used for testing per the instructions. Study staff will interpret and share the Lucira COVID-19 All-In-One Test Kit result with study subjects.
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 self-collected, prepared in Transport Medium and sent to the reference laboratory as directed by the Study Operations Manual.
Each collection may have a maximum of two swabs, including retests, for a maximum of four swabs per visit.
- Conditions
- Covid19, Corona Virus Infection
- Being tested
- Lucira COVID-19 All-In-One test kit
- Medical subject headings
- COVID-19, 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 start9 Dec 2020
- Primary completion9 Mar 2021
- Study completion30 Mar 2021
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
- 304 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
- NCT04720235
- Sponsor's protocol ID
- 07A-CLI-007
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 12 Apr 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 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay Among Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT04720235
- Acronym / sponsor ID
- 07A-CLI-007
- Conditions
- Covid19, Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Lucira Health IncIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (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.
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.
Detailed description
This Lucira COVID-19 All-In-One Test Kit recently received FDA Emergency Use Authorization (EUA) for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. The basis for this FDA EUA authorization was Lucira Health's first Community Testing study (07A-CLI-006) conducted among individuals suspected of COVID-19. This follow on 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 among asymptomatic individuals. The results of this study will be used to support an expanded indication for the Lucira COVID-19 All-In-One Test Kit among asymptomatic individuals.
This performance study will include the collection of subject demographics and nasal swabs self-collected by study subjects at community-based locations with trained medical staff oversight.
After determining subject eligibility and following the completion of the informed consent process, each subject will receive a unique study identification number.
A subject's participation in this study will consist of one study visit with one collection event. The subject self-collects a nasal swab sample and runs the Lucira COVID-19 All-In-One Test Kit according to the FDA EUA authorized package insert instructions.
Subject will be observed during the swabbing collection by the study staff and study staff will document collection details and any collection issues. Nasal swabs obtained from self-collection will be discarded after having been used for testing per the instructions. Study staff will interpret and share the Lucira COVID-19 All-In-One Test Kit result with study subjects.
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 self-collected, prepared in Transport Medium and sent to the reference laboratory as directed by the Study Operations Manual.
Each collection may have a maximum of two swabs, including retests, for a maximum of four swabs per visit.
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
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 14-75
- Must be able to read and write in English
- Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
Key exclusion criteria (14 listed)
- Currently suffering from nasal trauma such as a nosebleed
- Received a nasal rinse/wash/aspirates in past 12 hours
- Currently experiencing any of the CDC COVID-19 symptoms:
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 12 Apr 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 Corona Virus Infection, 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 3 inclusion and 14 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 12 Apr 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 12 Apr 2021.