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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
Sponsor:
Collaborators:
Buraidah Central Hospital
King Khalid University Hospital
Princess Nourah Bint Abdulrahman University
Information provided by (Responsible Party):
Hakeam Abdulaziz Hakeam, King Faisal Specialist Hospital & Research Center

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.

Condition or disease Intervention/treatment
COVID-19 Drug: Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)

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.

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Study Type : Observational
Actual Enrollment : 314 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.
Other Names:
  • ACE-I
  • ARB




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population will include patients admitted in King Faisal Specialist Hospital and Reseach Centre (KFSH&RC) Riyadh, Saudi Arabia.
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

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): NCT04357535


Locations
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Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
Hakeam Abdulaziz Hakeam
Buraidah Central Hospital
King Khalid University Hospital
Princess Nourah Bint Abdulrahman University
Investigators
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Principal Investigator: Hakeam A Hakeam, MSPharm BCPS King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT04357535    
Other Study ID Numbers: 2210061
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: On publication, according to the journal requirements

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hakeam Abdulaziz Hakeam, King Faisal Specialist Hospital & Research Center:
Coronavirus Disease 2019
Angiotensin Converting Enzyme Inhibitors
Angiotensin II Receptor Blockers
Additional relevant MeSH terms:
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Angiotensin II
Giapreza
Enzyme Inhibitors
Angiotensinogen
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors