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

NCT04357535 | Completed FDA Drug

• 1 other identifier: 2210061
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Coronavirus Disease 2019; Angiotensin Converting Enzyme Inhibitors; Angiotensin II Receptor Blockers

Outcome Measures

Primary Outcomes (1)

• Severity of COVID-19 Infection

  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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

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)

Interventions

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.

Also known as: ACE-I, ARB

Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Hakeam Abdulaziz Hakeam: lead
• Buraidah Central Hospital: collaborator
• King Khalid University Hospital: collaborator
• Princess Nourah Bint Abdulrahman University: collaborator

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (6)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

  PMID: 32015507 BACKGROUND

• Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

  PMID: 32167524 BACKGROUND

• Patel AB, Verma A. COVID-19 and Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers: What Is the Evidence? JAMA. 2020 May 12;323(18):1769-1770. doi: 10.1001/jama.2020.4812. No abstract available.

  PMID: 32208485 BACKGROUND

• Esler M, Esler D. Can angiotensin receptor-blocking drugs perhaps be harmful in the COVID-19 pandemic? J Hypertens. 2020 May;38(5):781-782. doi: 10.1097/HJH.0000000000002450. No abstract available.

  PMID: 32195824 BACKGROUND

• Hakeam HA, Alsemari M, Duhailib ZA, Ghonem L, Alharbi SA, Almutairy E, Sheraim NMB, Alsalhi M, Alhijji A, AlQahtani S, Khalid M, Barry M. Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Blockers With Severity of COVID-19: A Multicenter, Prospective Study. J Cardiovasc Pharmacol Ther. 2021 May;26(3):244-252. doi: 10.1177/1074248420976279. Epub 2020 Nov 24.

  PMID: 33231487 DERIVED

Related Links

• World Health Organization Data

MeSH Terms

Conditions

COVID-19

Interventions

Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Hakeam A Hakeam, MSPharm BCPS

  King Faisal Specialist Hospital and Research Centre (KFSH&RC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist, Surgery. Pharmaceutical Care Division, King Faisal Specialist Hospital & Research Centre. Adjunct Assistant Clinical Professor College of Medicine, Alfaisal University.

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: May 10, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

SA (1)