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

NCT04842708 | Completed

• 1 other identifier: Cov-2-SMC-V-2020
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between VOCs profile and participants' clinical or demographic characteristics

  Through the study completion, up to 1 month.

Study Arms (2)

Healthy Volunteers that are not to be vaccinated against COVID19

NO INTERVENTION

Healthy Volunteers that are not eligible to be vaccinated against COVID19

Healthy Volunteers that are assigned to be vaccinated against COVID19

EXPERIMENTAL

Healthy Volunteers that are eligible to be vaccinated against COVID19

Diagnostic Test: vaccination against COVID19

Interventions

vaccination against COVID19 DIAGNOSTIC_TEST

subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.

Healthy Volunteers that are assigned to be vaccinated against COVID19

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years old
• Under guardianship or deprived of liberty
• Pregnant or lactating woman
• Not eligible for anti-COVID-19 vaccination

Sponsors & Collaborators

• Scentech Medical Technologies Ltd: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shai Efrati, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: April 13, 2021
• Study Start: December 24, 2020
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)