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Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19 (BRACE-CORONA)

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ClinicalTrials.gov Identifier: NCT04364893
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Brazilian Clinical Research Institute
Information provided by (Responsible Party):
D'Or Institute for Research and Education

Study Description
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Brief Summary:
Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

Condition or disease Intervention/treatment Phase
Corona Virus Infection COVID-19 Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Group 1
Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
 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
Group 2
Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
 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


Outcome Measures
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Primary Outcome Measures :
  1. Median days alive and out of the hospital [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Number of participants with adverse cardiovascular outcomes and new worsening heart failure [ Time Frame: 30 days ]
    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

  2. Cardiovascular biomarkers related to COVID-19 [ Time Frame: up to 30 days ]
    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].


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364893


Contacts
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Contact: Renato D. Lopes, MD, PhD 55 11 5904 7339 renato.lopes@duke.edu

Locations
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Brazil
Idor Recruiting
São Paulo, Brazil
Contact: Renato D. Lopes, MD, PhD         
Sponsors and Collaborators
D'Or Institute for Research and Education
Brazilian Clinical Research Institute
Investigators
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Principal Investigator: Renato D. Lopes, MD, PhD D'Or Institute for Research and Education
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Lopes RD, Macedo AVS, de Barros E Silva PGM, Moll-Bernardes RJ, Dos Santos TM, Mazza L, Feldman A, D'Andréa Saba Arruda G, de Albuquerque DC, Camiletti AS, de Sousa AS, de Paula TC, Giusti KGD, Domiciano RAM, Noya-Rabelo MM, Hamilton AM, Loures VA, Dionísio RM, Furquim TAB, De Luca FA, Dos Santos Sousa ÍB, Bandeira BS, Zukowski CN, de Oliveira RGG, Ribeiro NB, de Moraes JL, Petriz JLF, Pimentel AM, Miranda JS, de Jesus Abufaiad BE, Gibson CM, Granger CB, Alexander JH, de Souza OF; BRACE CORONA Investigators. Effect of Discontinuing vs Continuing Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers on Days Alive and Out of the Hospital in Patients Admitted With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):254-264. doi: 10.1001/jama.2020.25864.

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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04364893    
Other Study ID Numbers: PRJ_2003
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by D'Or Institute for Research and Education:
Blockers of angiotensin receptor
Angiotensin-converting enzyme inhibitors
SARS-CoV2
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Respiratory Tract Infections
Respiratory Tract Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors