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NCT04493359 Clinical Trial

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

Covid19 Clinical Trial

— SWITCH-COVID  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04493359
Other study ID # 33575220.9.0000.0068
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date July 25, 2020
Est. completion date September 28, 2021

Study information
Verified date September 2021
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date September 28, 2021
Est. primary completion date September 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Renin-angiotensin system inhibitors
switch anti-hypertensive class

Locations
Country Name City State
Brazil Instituto do Coração - Incor HCFMUSP São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Need for ICU or mortality Combined of need for ICU or mortality 30 days
Secondary High sensitivity troponin levels and covid-19 severity Evaluate correlation between hs-TnT and covid-19 severity 30 days
Secondary ACE-2 activity and disease severity Evaluate correlation of ACE-2 activity and disease severity 30 days
Secondary ACE-2 activity with different Renin-angiotensin system inhibitors Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors 30 days
Secondary Blood control and acute renal failure Evaluate blood pressure control and acute renal failure in each arm (safety) 30 days
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