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

Scentech Medical Technologies

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: vaccination against COVID19

Study type: Interventional

Funder types: Industry

Identifiers

NCT04842708

Cov-2-SMC-V-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Healthy Volunteers that are not to be vaccinated against COVID19

No Intervention group

Description:

Healthy Volunteers that are not eligible to be vaccinated against COVID19

Healthy Volunteers that are assigned to be vaccinated against COVID19

Experimental group

Description:

Healthy Volunteers that are eligible to be vaccinated against COVID19

Treatment:

Diagnostic Test: vaccination against COVID19