COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX)
OBELIX
1 other identifier
observational
52
1 country
1
Brief Summary
The current COVID-19 pandemic (caused by the SARS-CoV-2 virus) represents the biggest medical challenge in decades. Whilst COVID-19 mainly affects the lungs it also affects multiple organ systems, including the cardiovascular system. There are documented associations between severity of disease and risk of death and To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section. 5 DRAFT Full Set of Project Data IRAS Version 5.13 advancing age, male sex and associated comorbid disease (hypertension, ischaemic heart disease, diabetes, obesity, COPD and cancer). The most common complications include cardiac dysrhythmia, cardiac injury, myocarditis, heart failure, pulmonary embolism and disseminated intravascular coagulation. It is thought that the mechanism of action of the virus involves binding to a host transmembrane enzyme (angiotensin- converting enzyme 2 (ACE2)) to enter some lung, heart and immune cells and cause further damage. While ACE2 is essential for viral invasion, it is unclear if the use of the common antihypertensive drugs ACE inhibitors or angiotensin receptor blockers (ARBs) alter prognosis. This study aims to look closely at the health of the vascular system of patients after being treated in hospital for COVID-19 (confirmed by PCR test) and compare them to patients who had a hospital admission for suspected COVID-19 (negative PCR test) . Information from this study is essential so that clinicians treating patients with high blood pressure understand the impact of the condition and these hypertension medicines in the context of the current COVID-19 pandemic. This will allow doctors to effectively treat and offer advice to patients currently prescribed these medications or who are newly diagnosed with hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 9, 2023
February 1, 2021
1.1 years
May 22, 2020
November 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
ABPM systolic blood pressure
Ambulatory Blood Pressure Monitoring systolic blood pressure
24 hours (all day and night)
Secondary Outcomes (12)
24-hr ABPM DBP
24 hours (all day and night)
day ABPM SBP
8am to 8pm
day ABPM DBP
8am to 8pm
night ABPM SBP
8pm to 8am
night ABPM DBP
8pm to 8am
- +7 more secondary outcomes
Study Arms (2)
COVID+ PCR
Subjects who are SARS-CoV-2 PCR+ve and/or have diagnostic CXR or CT chest features of COVID -19
COVID- PCR
subjects admitted with COVID-19 like symptoms but are SARS-CoV-2 PCR-ve and have CXR or CT chest that show low probability of COVID-19 will form the control group
Interventions
Eligibility Criteria
Patients admitted through QEUH immediate assessment unit and acute receiving units with suspected or confirmed COVID-19 during 01/04/20 - 31/12/20 and who are alive at discharge. Clinically suspected COVID-19 should have at least two of the following presenting features (fever, new onset cough, fatigue, myalgia, breathlessness, GI symptoms, anosmia/dysgeusia, contact with known COVID-19 positive patient).
You may qualify if:
- Admission between 01/04/2020 and 31/12/2020 Clinically suspected or PCR confirmed COVID-19 Age 30-60 years No history of hypertension or current drug treatment for hypertension
You may not qualify if:
- Inability to give informed consent/lack of capacity Non-English speakers BMI \>40 eGFR \<60 ml/min Pregnancy History of Cancer within 5 years Persistent atrial fibrillation Severe illness, at investigator discretion Prescription of BP lowering drugs Corticosteroid (chronic use) Immunosupressive agents NSAIDs (chronic use)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Study Sites (1)
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Biospecimen
blood and urine samples for vascular phenotpying marker, immuno phenotyping markers and future biomarker studies
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
June 1, 2020
Study Start
June 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
November 9, 2023
Record last verified: 2021-02