Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19

COVID-19 Clinical Trial

— BRACE-CORONA  

Official title:

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection (COVID-19). A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364893
• Other study ID #: PRJ_2003
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: D'Or Institute for Research and Education
• Contact: Renato D. Lopes, MD, PhD
• Phone: 55 11 5904 7339
• Email: renato.lopes[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

Description:

Several interactions by pre-existing therapies for chronic diseases, therapies used by SARS-CoV2 infection generate doubts about risks and benefits. Among these situations in which the current data indicate a situation of equipoise would be about the maintenance or suspension of ACEI / BRA in patients with SARS-CoV2 infection. Increasing the expression of ECA-2 could increase the binding to the virus, however, there are studies that indicate this increase in ECA-2 could be protective. So far, there is no clinical evidence to confirm any of the theories, and this question can only be clarified through a randomized clinical trial.

The objective is to evaluate the impact of the suspension of the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (BRA) on the length of hospital stay and on the mortality of patients with SARS-CoV2 infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized with COVID-19 diagnosis using ACE inhibitors or blockers of angiotensin receptor;

• Patients = 18 years old;

• Maximum use of 3 antihypertensive drugs;

• Sign the consent form.

Exclusion Criteria:

• Severe evolution with orotracheal intubation, use of mechanical ventilation and / or hemodynamic instability in the first 24 hours until COVID-19 diagnosis confirmation;

• Patients hospitalized per decompensated congestive heart failure in the last 12 months;

• Use of Sacubitril/Valsartan

• Pregnancy

• Recent acute renal failure and shock

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Locations

Country	Name	City	State
Brazil	Idor	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Brazilian Clinical Research Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median days alive and out of the hospital	The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.	30 days
Secondary	Number of participants with adverse cardiovascular outcomes and new worsening heart failure	Cardiovascular outcomes such as progression of COVID-19, mortality (general and cardiovascular), acute myocardial infarction, stroke / TIA, new heart failure or worsening of pre-existing HF, myocarditis, pericarditis, arrhythmias requiring treatment, phenomena thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure. All events will be reported according to CTCAE 4.0	30 days
Secondary	Cardiovascular biomarkers related to COVID-19	Evaluate levels of biomarkers [troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics].	up to 30 days