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

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ClinicalTrials.gov Identifier: NCT04842708
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Covid19 Diagnostic Test: vaccination against COVID19 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 : October 24, 2021
Estimated Study Completion Date : October 24, 2021

Arm Intervention/treatment
No Intervention: Healthy Volunteers that are not to be vaccinated against COVID19
Healthy Volunteers that are not eligible to be vaccinated against COVID19
Experimental: Healthy Volunteers that are assigned to be vaccinated against COVID19
Healthy Volunteers that are eligible to be vaccinated against COVID19
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.




Primary Outcome Measures :
  1. Association between breath VOCs and IgG in blood following second vaccination dose. [ Time Frame: Through the study completion, up to 1 month. ]
    VOCs profile found in breath will be correlatated with IgG profile in blood.


Secondary Outcome Measures :
  1. Association between VOCs profile and participants' clinical or demographic characteristics [ Time Frame: Through the study completion, up to 1 month. ]
    Identify potential exhaled biomarkers association with participants' characteristics (age, gender, symptoms-severity, etc.)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842708


Contacts
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Contact: Natalie Dror, PhD +972-528-264282 natalie@scentech-medical.com

Locations
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Israel
Shamir Medical Center Recruiting
Be'er Ya'aqov, Israel
Contact: Yair Bechor, PhD    +97253745624    YairB@shamir.gov.il   
Sponsors and Collaborators
Scentech Medical Technologies Ltd
Investigators
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Principal Investigator: Shai Efrati, MD Shamir Medical Center
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Responsible Party: Scentech Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT04842708    
Other Study ID Numbers: Cov-2-SMC-V-2020
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is not to be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs