Protocol summary
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Study aim
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The comparison of the clinical outcomes of patients with COVID -19 consuming renin-angiotensin-aldosterone system inhibitors with ceasing their consumption for whom calcium channel blockers with or without beta-blockers are prescribed according to the blood pressure and medication dosage.
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Design
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A randomized triple-blind clinical trial with parallel groups
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Settings and conduct
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The randomized clinical trial study will be performed in Sina and Imam-Khomeini Hospitals with triple-blinding of data recruiter, patients, and the data analyzer
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients who have suggestive signs of COVID-19 in their chest computed tomography scan, reported by a radiologist. Patients consuming angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
Exclusion criteria: Uncontrolled hypertension with systolic blood pressure more than 180 or diastolic more than 120; past history of congestive heart failure or arrhythmia with various severity; sensitivity to the newly prescribed medications; a history of severe asthma; a history of known depression; consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy; pregnancy; patient unwillingness to enter the study; patients whose prognosis is influenced by another disease
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Intervention groups
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1) Patients continuing to consume medications inhibiting renin-angiotensin-aldestrone system
2) Patients whose medication inhibiting renin-angiotensin-aldestrone system is discontinued and substituted by a calcium channel blocker with or without a beta blocker
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Main outcome variables
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Death; ICU admission
General information
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Reason for update
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To add Imam-Khomeini Hospital in conducting the study
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Acronym
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corona virus disease-2019 (COVID-19)
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IRCT registration information
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IRCT registration number:
IRCT20151113025025N3
Registration date:
2020-03-29, 1399/01/10
Registration timing:
prospective
Last update:
2020-07-06, 1399/04/16
Update count:
1
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Registration date
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2020-03-29, 1399/01/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-05, 1399/01/17
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Expected recruitment end date
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2020-09-21, 1399/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
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Public title
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Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who have suggestive signs of COVID-19 in their chest computed tomography scan, reported by a radiologist
Patients consuming angiotensin converting enzyme-inhibitors or angiotensin receptor blocker
Exclusion criteria:
Uncontrolled hypertension with systolic blood pressure more than 180 or diastolic more than 120
Past history of congested heart failure or arrhythmia with various severity
Sensitivity to the newly-prescribed medications
History of severe asthma
History of known depression
Consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy
Pregnancy
Patient unwillingness to enter the study
Patients whose prognosis is influenced by another disease
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Age
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From 18 years old
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Gender
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Both
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Phase
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4
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients consuming renin-angiotensin-aldosterone system inhibitors are recruited in the study using computerized-sequence random codes in 2 groups.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The physicians recruiting patients' data and the statistician are blinded whether the antihypertensive medication will be continued or withheld.
A pharmacotherapist will consult with a cardiologist for the patient group whose antihypertensive medication should be changed. At the time of discharge, this medication will be prescribed by the cardiologist who is not blinded and not responsible for data gathering.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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1985-06-17, 1364/03/27
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Ethics committee reference number
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IR.TUMS.VCR.REC.1399.028
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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corona virus disease 2019
Primary outcomes
1
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Description
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Death
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Timepoint
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3 months
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Method of measurement
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Number of deceased patients
Secondary outcomes
1
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Description
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ICU admission
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Timepoint
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6 months
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Method of measurement
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Number of deceased patients
Intervention groups
1
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Description
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Intervention group: Discontinuation of agents inhibiting renin-angiotensin-aldosterone system substituting by calcium channel blocker with or without beta-blocker
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Category
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Treatment - Drugs
2
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Description
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Control group: Continuation of renin-angiotensin-aldosterone inhibiting agents
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data will be shared if a journal wants to.
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When the data will become available and for how long
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At the time of publishing the article
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To whom data/document is available
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Journal editor or reviewers
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Under which criteria data/document could be used
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In case of a request from journal reviewers or editors
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From where data/document is obtainable
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They can email me.
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What processes are involved for a request to access data/document
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They can email me.
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Comments
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