SARS-CoV-2 Acute Respiratory DiseaseNCT05042193
A Prospective Virtual Study to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by Everly Health at 1 site in United States.
Trial summary
The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 1,883 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 14 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.
Who may be able to join
- Age ≥ 18 years
- Willing to provide informed consent prior to participation.
- Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
- Cohort 2 (Arm 2) - Received the COVID-19 vaccine
Who cannot join
- Unable or unwilling to provide informed consent
- Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co
The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.
Read the detailed description
This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2Other
Observational
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated SARS-CoV-2 positive | Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated Receives: Other: SARS-CoV-2 | |
| Vaccinated | Participants who were vaccinated against SARS-CoV-2 Receives: Other: SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
Measured: Up to 9 months
Secondary outcomes (2)
To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load
Measured: Up to 9 months
To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start19 Mar 2021
- Primary completion31 May 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,883 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everly Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bauer, PhD, Principal investigator, Everly Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042193
- Sponsor's protocol ID
- EW-US-4010-0007
- Status last verified
- Jun 2022
- First submitted
- 9 Sep 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co
- ClinicalTrials.gov ID
- NCT05042193
- Acronym / sponsor ID
- EW-US-4010-0007
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,883 participants (actual)
- Lead sponsor
- Everly HealthIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 13 Sep 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.
The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.
Detailed description
This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated SARS-CoV-2 positive | – | Other: SARS-CoV-2Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated |
| Vaccinated | – | Other: SARS-CoV-2Participants who were vaccinated against SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Willing to provide informed consent prior to participation.
- Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
- Cohort 2 (Arm 2) - Received the COVID-19 vaccine
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy
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 |
|---|---|---|
| SARS-CoV-2Observational | Other | Unvaccinated SARS-CoV-2 positive, Vaccinated |
Primary outcome
To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
Time frame: Up to 9 months
2 secondary outcomes
To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load
Time frame: Up to 9 months
To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination
Time frame: Up to 9 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 15 Jun 2022.
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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.
Timothy Bauer, PhD principal investigator
Everly Health
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-2 Acute Respiratory Disease, run by Everly Health 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 4 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 15 Jun 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?
To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2 (time frame: Up to 9 months). 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 15 Jun 2022.