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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vaccination against COVID19
Sponsored by
Scentech Medical Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Shamir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Healthy Volunteers that are not to be vaccinated against COVID19

Healthy Volunteers that are assigned to be vaccinated against COVID19

Arm Description

Healthy Volunteers that are not eligible to be vaccinated against COVID19

Healthy Volunteers that are eligible to be vaccinated against COVID19

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Association between VOCs profile and participants' clinical or demographic characteristics
Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)

Full Information

First Posted
December 29, 2020
Last Updated
February 3, 2022
Sponsor
Scentech Medical Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04842708
Brief Title
Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Acronym
COVID-19
Official Title
Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scentech Medical Technologies Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers that are not to be vaccinated against COVID19
Arm Type
No Intervention
Arm Description
Healthy Volunteers that are not eligible to be vaccinated against COVID19
Arm Title
Healthy Volunteers that are assigned to be vaccinated against COVID19
Arm Type
Experimental
Arm Description
Healthy Volunteers that are eligible to be vaccinated against COVID19
Intervention Type
Diagnostic Test
Intervention Name(s)
vaccination against COVID19
Intervention Description
subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.
Primary Outcome Measure Information:
Title
Association between breath VOCs and IgG in blood following second vaccination dose.
Description
VOCs profile found in breath will be correlatated with IgG profile in blood.
Time Frame
Through the study completion, up to 1 month.
Secondary Outcome Measure Information:
Title
Association between VOCs profile and participants' clinical or demographic characteristics
Description
Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)
Time Frame
Through the study completion, up to 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD is not to be shared with other researchers.

Learn more about this trial

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

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