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NCT04842708 | Completed | Covid19


Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Sponsor:

Scentech Medical Technologies Ltd

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.

Condition or disease

Covid19

Intervention/treatment

vaccination against COVID 19

Phase

Not Applicable

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 : Interventional
Estimated Enrollment : 43 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Actual Study Start Date : December 24, 2020
Estimated Primary Completion Date : December 24, 2021
Estimated Study Completion Date : December 24, 2021
Arm Intervention/treatment

No Intervention: Healthy Volunteers that are not to be vaccinated against COVID 19

Healthy Volunteers that are not eligible to be vaccinated against COVID 19

Experimental: Healthy Volunteers that are assigned to be vaccinated against COVID 19

Healthy Volunteers that are eligible to be vaccinated against COVID 19

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Israel,

Shamir Medical Center

Bir Yaqif, Israel,

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