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

Not Applicable

• Conditions: COVID-19; Corona Virus Infection
• Interventions: Other: Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

• Registration Number: NCT04364893
• Lead Sponsor: D'Or Institute for Research and Education

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-04-07
• Study Start: 2020-04-09
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors	Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
Group 2	Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors	Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors

Primary Outcome Measures

Name	Time	Method
Median days alive and out of the hospital	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

Name	Time	Method
Number of participants with adverse cardiovascular outcomes and new worsening heart failure	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
Cardiovascular biomarkers related to COVID-19	up to 30 days	Evaluate levels of biomarkers \[troponin, type B natriuretic peptide (BNP), N-terminal natriuretic peptide type B (NT-ProBNP), D-dimer, total lymphocytes , CD4, CD8, macrophages, cytokines, in addition to biomarkers detected by proteomics and metabolomics\].

Trial Locations

Locations (1)

Idor; 🇧🇷 São Paulo, Brazil