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Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis (COVID-19)

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ClinicalTrials.gov Identifier: NCT04842708
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Scentech Medical Technologies Ltd

Tracking Information
First Submitted Date  ICMJE December 29, 2020
First Posted Date  ICMJE April 13, 2021
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE December 24, 2020
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2021)
Association between breath VOCs and IgG in blood following second vaccination dose. [ Time Frame: Through the study completion, up to 1 month. ]
VOCs profile found in breath will be correlatated with IgG profile in blood.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2021)
Association between VOCs profile and participants' clinical or demographic characteristics [ Time Frame: Through the study completion, up to 1 month. ]
Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Official Title  ICMJE Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Brief Summary

The objective of this study will be to evaluate the effect of vaccination on breath VOC content.

By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.

Detailed Description

The objective of this study will be to evaluate the effect of vaccination on breath VOC content.

By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.

Rapidly growing serological evidence shows that IgM, IgG, and IgA antibodies against the S or N proteins evolve rapidly in the serum of asymptomatic as well as symptomatic COVID-19 patients within a week of infection or symptom onset and stay elevated with progressing disease.

Since the standard serology testing at Shamir Medical center tracks the presence of IgG only, those serologic tests will be conducted before and 48 hours following the second vaccination dose.

Nevertheless, since IgM antibodies are known to be produced by four to seven days following the first dose of vaccination, although IgM serology testing cannot be performed, the investigators are interested in sampling breath at this time range, in order for them to correlate it with the changes in the subjects' physiologic condition.

Since this is an unknown metabolic volatile compound mixture, the goal will be to identify compounds and quantify them with a high level of precision and subsequently correlate them with the disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Covid19
Intervention  ICMJE Diagnostic Test: vaccination against COVID19
subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.
Study Arms  ICMJE
  • No Intervention: Healthy Volunteers that are not to be vaccinated against COVID19
    Healthy Volunteers that are not eligible to be vaccinated against COVID19
  • Experimental: Healthy Volunteers that are assigned to be vaccinated against COVID19
    Healthy Volunteers that are eligible to be vaccinated against COVID19
    Intervention: Diagnostic Test: vaccination against COVID19
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 24, 2021
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 75 years at the time of consent
  • Capable of understanding written and/or spoken language
  • Able to provide informed consent
  • Assigned to undergo anti-COVID-19 vaccination

Exclusion Criteria:

  • Age under 18 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman
  • Not eligible for anti-COVID-19 vaccination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Natalie Dror, PhD +972-528-264282 natalie@scentech-medical.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04842708
Other Study ID Numbers  ICMJE Cov-2-SMC-V-2020
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  ICMJE
Plan to Share IPD: No
Plan Description: IPD is not to be shared with other researchers.
Responsible Party Scentech Medical Technologies Ltd
Study Sponsor  ICMJE Scentech Medical Technologies Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shai Efrati, MD Shamir Medical Center
PRS Account Scentech Medical Technologies Ltd
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP