Switch of Renin-Angiotensin System Inhibitors in Patients... | NCT04493359

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

NCT04493359

Sponsor

University of Sao Paulo

Status

Terminated

Last Update Posted

Oct 6, 2021Actual

Enrollment

18Actual

Phase

Phase 2Phase 3

Conditions

Covid19
Angiotensin II Receptor Antagonist Adverse Reaction

Interventions

Renin-angiotensin system inhibitors

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dificulteis in enrolling patients

Expanded Access Info

Start Date

Jul 25, 2020Actual

Primary Completion Date

Sep 28, 2021Actual

Completion Date

Sep 28, 2021Actual

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 29, 2020

First Posted Date

Jul 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2021

Last Update Posted Date

Oct 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Switch therapy	Experimental	Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.	Drug: Renin-angiotensin system inhibitors
Maintenance therapy	No Intervention	Renin-angiotensin system inhibitors will be kept during in-hospital stay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renin-angiotensin system inhibitors	Drug	switch anti-hypertensive class	Switch therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Coração - Incor HCFMUSP		São Paulo	São Paulo	05403-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data may be requested for collaboration projects

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided