The Burden of Lyme Disease (BOLD) in a Pandemic - Insight... | NCT05312619

Studies
The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey

NCT05312619

Sponsor

Dr. Daniel Cameron & Associates

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

COVID-19
Lyme Disease
COVID-19 Vaccine

Interventions

Cross sectional survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Jul 7, 2023Estimated

Completion Date

Nov 7, 2023Estimated

First Submitted Date

Mar 28, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Apr 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniel Cameron, Chief Investigator, Dr. Daniel Cameron & AssociatesPrincipal Investigator

Lead Sponsor

Dr. Daniel Cameron & AssociatesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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:

1. 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?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cross sectional survey	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)	Cross sectional	7/21 to 7/23

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥12 years old
a self-report of having been diagnosed with Lyme disease.

Exclusion Criteria:

There are no exclusion criteria.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Cameron, MD, MPH	Contact	9143251471		dcameron@danielcameronmd.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daniel Cameron	Recruiting	Mount Kisco	New York	10549	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D008193	Lyme Disease

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003430	Cross-Sectional Studies

Ancestor Terms

ID	Term
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided