Prognosis of SARS-Cov 2 Positive Patients Receiving Angiotensin Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Antagonists (ARBs)
Overview
- Phase
- Not Applicable
- Intervention
- Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)
- Conditions
- COVID-19
- Sponsor
- Hakeam Abdulaziz Hakeam
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- Severity of COVID-19 Infection
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Coronavirus disease 2019 (COVID-19) ,caused by the newly identified Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus, has shown substantial global spread affecting over 2 million people and claiming over 120,000 lives to date. In March 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. The spectrum of manifestations of COVID19 infection ranges from mild flu-like symptoms to severe acute respiratory distress syndrome (ARDS), with an associated fatality rate of 1.4%. The suggested mode of entry of the SARS-CoV-2 into the human respiratory epithelium is through the angiotensin-converting enzyme 2 (ACE2) protein expressed on alveolar cell surfaces. This entry mechanism has sparked the interest of the scientific community. Preliminary epidemiological reports showed an increased risk of ARDS in hypertensive COVID-19 patients. This leads to the hypothesis that hypertensives treated with angiotensin-converting enzyme inhibitor (ACE-I) are at an increased risk of developing complicated COVID-19 infections . Other studies have refuted these claims as unsupported. Studies revealing the up regulation of ACE2 in cells of patients treated with ACE-I or ARBs were the underlying foundation for these claims. This study aims to assess the impact of ACE-I and/or ARBs on the prognosis of patients with COVID19.
Detailed Description
Design and Patients: this is a prospective, observational multi-center study, to be conducted at King Faisal Specialist Hospital and Research Centre (KFSH \& RC), Riyadh, Saudi Arabia as a primary center. Collaborating centers are Buraidah Central hospital,King Khalid University Hospital and King Abdullah bin Abdulaziz University Hospital (affiliate of Princess Nourah Bint Abdulrahman University) Sample size: 226 subjects. Protocol: Patients diagnosed with COVID19 infection via positive polymerase chain reaction (PCR) test will be screened for one of the following five comorbidity (hypertension, diabetes mellitus, cerebrovascular disease, coronary artery disease, and heart failure) will be identied on admission to hospital. The use of ACE-I and ARBs or other antihypertensive medications will be recorded. Additional information to be gathered will include the following: patient demographics (age, sex, weight, and height), indication for ACE-I or ARB therapy, duration therapy and doses; plasma or serum levels of the following laboratories will be obtained on admission: creatinine levels, lactate dehydrogenase, creatinine kinase, ferritin, D-Dimer, and c-reactive protein. The date of positive COVID19 PCR; admission to the intensive care unit (ICU) with calculating the Sequential Organ Failure Assessment (SOFA) score. The requirement of mechanical ventilation and vasopressors will be recorded with a length of ICU stay. Patients fulfilling the criteria of acute respiratory distress (ARDS) will be recorded, and the PF ratio will be assessed for all subjects admitted to the ICU. Patient who die in ICU or during hospitalization will be recorded. The entirety of the hospitalization period will be determined and recorded. Outcome Assessment: The primary endpoint will be the severity of COVID-19 infection, described as the composite of admission to the intensive care unit, requirement for invasive mechanical ventilation or death. The use of ACE-I and ARBs will be assessed independently for associations with severity of respiratory disease. The rate of patients using ACE-I or ARBs will be reported with the indications for their use. The association of ACE-I or ARBs with prognosis of patients with COVID19 will be reported.
Investigators
Hakeam Abdulaziz Hakeam
Clinical Pharmacy Specialist, Surgery. Pharmaceutical Care Division, King Faisal Specialist Hospital & Research Centre. Adjunct Assistant Clinical Professor College of Medicine, Alfaisal University.
King Faisal Specialist Hospital & Research Center
Eligibility Criteria
Inclusion Criteria
- •Criteria Include patients infected with the COVID19 (via positive PCR) aged ≥ 18 years with one of the following:
- •Hypertension
- •Coronary artery disease
- •Heart failure
- •Diabetes mellitus.
Exclusion Criteria
- •Pregnancy
Arms & Interventions
Primary Cohort
Patients enrolled in this study will have data collected from the beginning of their hospital stay until discharge. Data collected will include: * Patient demographics (age, sex, weight, and height) * Indication for ACE-I, ARB therapy, duration and doses * Use of any a non ACE-I/ ARB sntihypertensive agents * Comorbidities, and COVID19 related markers: Including WBC, plateltes, ferritin, CRP, CK, and LD * CT scan reports * First positive COVID19 PCR * Admission to the intensive care unit (ICU) and data relating to ICU stay.
Intervention: Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)
Outcomes
Primary Outcomes
Severity of COVID-19 Infection
Time Frame: From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.
Admission to intensive care unit, requirement for invasive ventilation or death
Secondary Outcomes
- Septic shock as defined by sepsis-3 criteria(From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.)
- Degree of severity of respiratory disease(From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.)