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(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.

Tracking Information
First Submitted Date December 29, 2021
First Posted Date February 11, 2022
Last Update Posted Date February 11, 2022
Actual Study Start Date April 15, 2021
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2022)
  • Collect bio signal data before and after vaccination in ~100 individuals using one or more wearable biosensors. [ Time Frame: December, 2022 ]
  • Evaluate the relationship between the MCI and individual bio signals parameters and the subjective symptoms experienced by participants. [ Time Frame: December, 2022 ]
  • Explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses. [ Time Frame: December, 2022 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title (VIII): The Eight Study and Immunologic Response Sub-study
Official Title Monitoring of Physiologic Changes Associated With Immune System Activation Associated With Vaccination Against the SARS-CoV-2 Virus: Vaccine-Induced Inflammation Identification
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults that plan to receive COVID-19 vaccine.
Condition Vaccine Reaction
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 2, 2022)		 130
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2022
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Maged Gendy 708-802-3797 maged.gendy@physiq.com
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05237024
Other Study ID Numbers CTP-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party physIQ, Inc.
Original Responsible Party Same as current
Current Study Sponsor physIQ, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Steve Steinhubl, MD CMO
PRS Account physIQ, Inc.
Verification Date February 2022