Prognosis of Coronavirus Disease 2019 (COVID-19) Patients Receiving Receiving Antihypertensives
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|ClinicalTrials.gov Identifier: NCT04357535|
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|COVID-19||Drug: Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)|
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.
|Study Type :||Observational|
|Actual Enrollment :||314 participants|
|Official Title:||Prognosis of SARS-Cov 2 Positive Patients Receiving Angiotensin Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Antagonists (ARBs)|
|Actual Study Start Date :||May 10, 2020|
|Actual Primary Completion Date :||July 1, 2020|
|Actual Study Completion Date :||August 1, 2020|
Patients enrolled in this study will have data collected from the beginning of their hospital stay until discharge.
Data collected will include:
Drug: Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)
ACE-I and ARB are a class of blood pressure lowering medications used to manage hypertension.
- 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
- Degree of severity of respiratory disease [ Time Frame: From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks. ]PaO2/FiO2 ratio (PF) ratio
- Septic shock as defined by sepsis-3 criteria [ Time Frame: From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks. ]Defined as sepsis with hypotension requiring vasopressors to maintain mean arterial pressure (MAP) 65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
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): NCT04357535
|King Faisal Specialist Hospital & Research Centre|
|Riyadh, Saudi Arabia, 11211|
|Principal Investigator:||Hakeam A Hakeam, MSPharm BCPS||King Faisal Specialist Hospital and Research Centre (KFSH&RC)|