Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19

Study Overview
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Brief Summary
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The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.

Detailed Description
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Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol. Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.

Official Title
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Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial

Conditions
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Covid19, Angiotensin II Receptor Antagonist Adverse Reaction

Intervention / Treatment
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* Drug: Renin-angiotensin system inhibitors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension in use of renin-angiotensin system inhibitors Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT. Symptoms onset < 96h Need for hospitalization Exclusion Criteria: Heart failure Previous cerebrovascular disease Previous myocardial infarction Blood pressure > 180 x 100 mmHg Need for 3 or more anti-hypertensive classes Use os spironolactone Severe pulmonary disease Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Switch therapy<br>Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes. | Drug: Renin-angiotensin system inhibitors<br>* switch anti-hypertensive class<br>|
| No Intervention: Maintenance therapy<br>Renin-angiotensin system inhibitors will be kept during in-hospital stay | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for ICU or mortality | Combined of need for ICU or mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sensitivity troponin levels and covid-19 severity | Evaluate correlation between hs-TnT and covid-19 severity | 30 days | 
| ACE-2 activity and disease severity | Evaluate correlation of ACE-2 activity and disease severity | 30 days | 
| ACE-2 activity with different Renin-angiotensin system inhibitors | Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors | 30 days | 
| Blood control and acute renal failure | Evaluate blood pressure control and acute renal failure in each arm (safety) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, ace inhibitors, ace2