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NCT Number: NCT04357535

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Faisal Specialist Hospital & Research Centre

Riyadh, 11211, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)

Drug

ACE-I and ARB are a class of blood pressure lowering medications used to manage hypertension.

Other names: ACE-I, ARB

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hakeam Abdulaziz Hakeam

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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