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

Covid19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842708
• Other study ID #: Cov-2-SMC-V-2020
• Status: Completed
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: December 24, 2021

Study information

• Verified date: February 2022
• Source: Scentech Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Scentech Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between breath VOCs and IgG in blood following second vaccination dose.	VOCs profile found in breath will be correlatated with IgG profile in blood.	Through the study completion, up to 1 month.
Secondary	Association between VOCs profile and participants' clinical or demographic characteristics	Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)	Through the study completion, up to 1 month.