Prognosis of Coronavirus Disease 2019 (COVID-19) Patients Receiving Receiving Antihypertensives

August 1, 2020 updated by: Hakeam Abdulaziz Hakeam

Prognosis of SARS-Cov 2 Positive Patients Receiving Angiotensin Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Antagonists (ARBs)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.
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.
From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hakeam Abdulaziz Hakeam

Collaborators

King Khalid University Hospital
Princess Nourah Bint Abdulrahman University
Buraidah Central Hospital

Investigators

  • Principal Investigator: Hakeam A Hakeam, MSPharm BCPS, King Faisal Specialist Hospital and Research Centre (KFSH&RC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2210061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

On publication, according to the journal requirements

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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