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

Phase 2

Terminated

• Conditions: Angiotensin II Receptor Antagonist Adverse Reaction; Covid19
• Interventions: Drug: Renin-angiotensin system inhibitors

• Registration Number: NCT04493359
• Lead Sponsor: University of Sao Paulo

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-25
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-30
• Status Verified: 2021-09
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Switch therapy	Renin-angiotensin system inhibitors	Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.

Primary Outcome Measures

Name	Time	Method
Need for ICU or mortality	30 days	Combined of need for ICU or mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto do Coração - Incor HCFMUSP; 🇧🇷 São Paulo, SP, Brazil