- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013177
Effect of COVID-19 Vaccine on Blood Pressure
August 17, 2021 updated by: Kelvin KF Tsoi, Chinese University of Hong Kong
The study aims to investigate (1) if COVID-19 vaccine impacts on blood pressure, (2) the extent of impact on blood pressure (if any), and (3) which groups of subjects are more susceptible to be affected by COVID-19 vaccine on blood
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Coronavirus disease 19 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has elicited global pandemic since January 2020.
Until the end of June 2021, the virus has caused 182 million confirmed COVID-19 cases and 3.95 million deaths worldwide.
To stop the spread of virus, there has been rapid development of vaccine against SARS-CoV-2.
Currently there has been 9 vaccines authorized for emergency use, and 8 vaccines received full approval for use in various countries.
Extensive studies have been showing the efficacy of different types of vaccines against COVID-19 and its variants.
Safety of COVID-19 vaccines has been a concern.
Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines.
One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT).
Case series report4 and observational studies on ChAdOx1 nCoV-19 vaccine showed high level of autoantibodies to platelet factor-4 (PF4) which could contribute to microvascular damage, micro-bleeding and platelet activation and therefore causes event of thrombosis.
Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure.
Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure along the time.
Given the vast population of hypertensive patients worldwide, the increasing number of people being vaccinated and the importance of blood pressure level to various human organs, it is essential to investigate the short- and long-term effect of COVID-19 vaccine on blood pressure.
Study Type
Observational
Enrollment (Anticipated)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants attending CUHK Medical Centre community vaccination centre or CUHK Medical Clinic to receive COVID-19 vaccination will be invited to the study.
Description
Inclusion Criteria:
- Subjects aged 18 years old or above
- Subjects with home blood pressure monitoring device
- Subjects with smartphone and with HealthCap application downloaded
- Subjects who understand Chinese to make an informed consent
Exclusion Criteria:
- Subjects unable to take regular home blood pressure measurement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate if COVID-19 vaccine impacts on blood pressure.
Time Frame: 6 weeks
|
To measure blood pressure at the time of COVID-19 vaccination and during follow-up
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
August 17, 2021
First Submitted That Met QC Criteria
August 17, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Actual)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021.448
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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