NCT05312619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 28, 2022

Last Update Submit

March 28, 2022

Conditions

COVID-19Lyme DiseaseCOVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

  • Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)

    Cross sectional

    7/21 to 7/23

Interventions

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

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daniel Cameron

Mount Kisco, New York, 10549, United States

RECRUITING

MeSH Terms

Conditions

COVID-19Lyme Disease

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Daniel Cameron, MD, MPH

CONTACT

9143251471dcameron@danielcameronmd.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 5, 2022

Study Start

July 7, 2021

Primary Completion

July 7, 2023

Study Completion

November 7, 2023

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)