COVID-19NCT05312619
The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey
An observational study of COVID-19 and Lyme Disease, run by Dr. Daniel Cameron & Associates at 1 site in United States.
Trial summary
A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19, Lyme Disease, COVID-19 Vaccine
- What is being tested?
- Cross sectional survey
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to 7 Nov 2023
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not.
Who may be able to join
- ≥12 years old
- a self-report of having been diagnosed with Lyme disease.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Daniel Cameron
Mount Kisco, New York, 10549
Daniel Cameron, MD, MPH, 914-325-1471, dcameron@danielcameronmd.com
About this study
Official title: The Burden of Lyme Disease (BOLD) in a Pandemic
A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.
Read the detailed description
Primary research question:
- Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?
Secondary research questions:
- Will the BOLD be worse for individuals who have been ill with COVID-19?
- What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
- If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
- What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
- What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?
- Conditions
- COVID-19, Lyme Disease, COVID-19 Vaccine
- Being tested
- Cross sectional survey
- Medical subject headings
- COVID-19, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross sectional surveyOther
A cross-sectional descriptive survey of the Burden of Lyme disease for individual with a history of Lyme disease who contract COVID-19 or are vaccinated against COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)
Cross sectional
Measured: 7/21 to 7/23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start7 Jul 2021
- Primary completion7 Jul 2023 (estimated)
- Study completion7 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Daniel Cameron & Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cameron, Dr. Daniel Cameron & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312619
- Sponsor's protocol ID
- 20212917
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Lyme Disease (BOLD) in a Pandemic
- ClinicalTrials.gov ID
- NCT05312619
- Acronym / sponsor ID
- 20212917
- Conditions
- COVID-19, Lyme Disease, COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Dr. Daniel Cameron & AssociatesUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Jul 2023 (estimated)
- Study completion
- 7 Nov 2023 (estimated)
- First posted
- 5 Apr 2022 (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.
A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.
Detailed description
Primary research question:
- Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?
Secondary research questions:
- Will the BOLD be worse for individuals who have been ill with COVID-19?
- What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
- If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
- What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
- What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not.
Key inclusion criteria (2 listed)
- ≥12 years old
- a self-report of having been diagnosed with Lyme disease.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
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 |
|---|---|---|
| Cross sectional surveyA cross-sectional descriptive survey of the Burden of Lyme disease for individual with a history of Lyme disease who contract COVID-19 or are vaccinated against COVID-19 | Other | – |
Primary outcome
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)
Time frame: 7/21 to 7/23
Cross sectional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- 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.
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 COVID-19 and Lyme Disease, run by Dr. Daniel Cameron & Associates 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 1 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: status not confirmed, as of the sponsor's last update on 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Cameron, MD, MPH (9143251471, dcameron@danielcameronmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30) (time frame: 7/21 to 7/23). 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 5 Apr 2022.