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Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19 (SWITCH-COVID)

Primary Purpose

Covid19, Angiotensin II Receptor Antagonist Adverse Reaction

Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Renin-angiotensin system inhibitors
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19, ace inhibitors, ace2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto do Coração - Incor HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Switch therapy

Maintenance therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Need for ICU or mortality
Combined of need for ICU or mortality

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2020
Last Updated
September 28, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04493359
Brief Title
Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19
Acronym
SWITCH-COVID
Official Title
Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Dificulteis in enrolling patients
Study Start Date
July 25, 2020 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Angiotensin II Receptor Antagonist Adverse Reaction
Keywords
covid19, ace inhibitors, ace2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Switch therapy
Arm Type
Experimental
Arm Description
Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.
Arm Title
Maintenance therapy
Arm Type
No Intervention
Arm Description
Renin-angiotensin system inhibitors will be kept during in-hospital stay
Intervention Type
Drug
Intervention Name(s)
Renin-angiotensin system inhibitors
Intervention Description
switch anti-hypertensive class
Primary Outcome Measure Information:
Title
Need for ICU or mortality
Description
Combined of need for ICU or mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
High sensitivity troponin levels and covid-19 severity
Description
Evaluate correlation between hs-TnT and covid-19 severity
Time Frame
30 days
Title
ACE-2 activity and disease severity
Description
Evaluate correlation of ACE-2 activity and disease severity
Time Frame
30 days
Title
ACE-2 activity with different Renin-angiotensin system inhibitors
Description
Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors
Time Frame
30 days
Title
Blood control and acute renal failure
Description
Evaluate blood pressure control and acute renal failure in each arm (safety)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Instituto do Coração - Incor HCFMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be requested for collaboration projects

Learn more about this trial

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

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