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NCT05312619 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
The Burden of Lyme Disease (BOLD) in a Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05312619
Other study ID # 20212917
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 7, 2021
Est. completion date November 7, 2023

Study information
Verified date March 2022
Source Dr. Daniel Cameron & Associates
Contact Daniel Cameron, MD, MPH
Phone 9143251471
Email dcameron@danielcameronmd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

Description:

Primary research question: 1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine? Secondary research questions: 1. Will the BOLD be worse for individuals who have been ill with COVID-19? 2. 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? 3. 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? 4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine? 5. 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?

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date November 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - =12 years old - a self-report of having been diagnosed with Lyme disease. Exclusion Criteria: - There are no exclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cross sectional survey
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

Locations
Country Name City State
United States Daniel Cameron Mount Kisco New York

Sponsors (1)
Lead Sponsor Collaborator
Dr. Daniel Cameron & Associates

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30) Cross sectional 7/21 to 7/23
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