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

NCT ID: NCT04493359

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-25

Study Completion Date

2021-09-28

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.

Conditions

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Covid19 Angiotensin II Receptor Antagonist Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Switch therapy

Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.

Group Type EXPERIMENTAL

Renin-angiotensin system inhibitors

Intervention Type DRUG

switch anti-hypertensive class

Maintenance therapy

Renin-angiotensin system inhibitors will be kept during in-hospital stay

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renin-angiotensin system inhibitors

switch anti-hypertensive class

Intervention Type DRUG

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Caramelli

MD. PHD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto do Coração - Incor HCFMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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33575220.9.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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