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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04493359
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Angiotensin II Receptor Antagonist Adverse Reaction	Drug: Renin-angiotensin system inhibitors	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
• Actual Study Start Date: Jul 25, 2020
• Actual Primary Completion Date: Sep 28, 2021
• Actual Study Completion Date: Sep 28, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Need for ICU or mortality [30 days]

   Combined of need for ICU or mortality

Secondary Outcome Measures

1. High sensitivity troponin levels and covid-19 severity [30 days]

   Evaluate correlation between hs-TnT and covid-19 severity

2. ACE-2 activity and disease severity [30 days]

   Evaluate correlation of ACE-2 activity and disease severity

3. ACE-2 activity with different Renin-angiotensin system inhibitors [30 days]

   Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors

4. Blood control and acute renal failure [30 days]

   Evaluate blood pressure control and acute renal failure in each arm (safety)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Coração - Incor HCFMUSP	São Paulo	SP	Brazil	05403-900

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruno Caramelli, MD. PHD., University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT04493359
• Other Study ID Numbers: 33575220.9.0000.0068
• First Posted: Jul 30, 2020
• Last Update Posted: Oct 6, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Bruno Caramelli, MD. PHD., University of Sao Paulo: covid19; ace inhibitors; ace2
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 6, 2021