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

September 28, 2021 updated by: Bruno Caramelli, University of Sao Paulo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-900
        • Instituto do Coração - Incor HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Switch therapy
Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.
Drug: Renin-angiotensin system inhibitors
switch anti-hypertensive class
No Intervention: Maintenance therapy
Renin-angiotensin system inhibitors will be kept during in-hospital stay

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2020

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33575220.9.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data may be requested for collaboration projects

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Renin-angiotensin system inhibitors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe