We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

(VIII): The Eight Study and Immunologic Response Sub-study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237024
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
physIQ, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.

Condition or disease
Vaccine Reaction

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Physiology Monitoring
The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors.
Physiology & Immune Monitoring
A limited sub-study including 30 individuals enrolled in the primary study (not retrospective group) will incorporate serial blood draws relative to the vaccine doses. The purpose of the serologies and immunoassays is to explore the correlation an individual's development of a vaccine-induced immune response with changes in the continuous physiologic data surrounding the immunization process.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors. [ Time Frame: December, 2022 ]
  2. Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. [ Time Frame: December, 2022 ]
  3. Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. [ Time Frame: December, 2022 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults that plan to receive COVID-19 vaccine.
Criteria

Inclusion Criteria:

  • Is 18 years of age or older.
  • Is able to speak and read English.
  • Plan to receive either the Moderna or Pfizer vaccine (mRNA vaccine).
  • No known prior COVID-19 infection.

Exclusion Criteria:

  • Known allergy to the adhesive used on the VitalPatch.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237024


Contacts
Layout table for location contacts
Contact: Maged Gendy 708-802-3797 maged.gendy@physiq.com

Locations
Layout table for location information
United States, Illinois
physIQ Recruiting
Chicago, Illinois, United States, 60606
Contact: Maged Gendy    708-802-3797    maged.gendy@physiq.com   
Canada, Quebec
Cell Carta Recruiting
Montréal, Quebec, Canada, H2X 3A3
Contact: Maged Gendy    708-802-3797    maged.gendy@physiq.com   
Sponsors and Collaborators
physIQ, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Steve Steinhubl, MD CMO
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: physIQ, Inc.
ClinicalTrials.gov Identifier: NCT05237024    
Other Study ID Numbers: CTP-024
First Posted: February 11, 2022    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No