Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT04357535
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2020-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Coronavirus Disease 2019 (COVID-19) Patients Receiving Receiving Antihypertensives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D057911', 'term': 'Angiotensin Receptor Antagonists'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-01', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of COVID-19 Infection', 'timeFrame': 'From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.', 'description': 'Admission to intensive care unit, requirement for invasive ventilation or death'}], 'secondaryOutcomes': [{'measure': 'Degree of severity of respiratory disease', 'timeFrame': 'From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.', 'description': 'PaO2/FiO2 ratio (PF) ratio'}, {'measure': 'Septic shock as defined by sepsis-3 criteria', 'timeFrame': 'From date of study enrolment until discharge from hospital or death from any cause, whichever came first, assessed up to 4 weeks.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus Disease 2019', 'Angiotensin Converting Enzyme Inhibitors', 'Angiotensin II Receptor Blockers'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32109013', 'type': 'BACKGROUND', 'citation': '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': '32015507', 'type': 'BACKGROUND', 'citation': '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': '32167524', 'type': 'BACKGROUND', 'citation': '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': '32208485', 'type': 'BACKGROUND', 'citation': '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': '32195824', 'type': 'BACKGROUND', 'citation': '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': '33231487', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/emergencies/diseases/novel-coronavirus-2019', 'label': 'World Health Organization Data'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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)\n\nSample size: 226 subjects.\n\nProtocol: 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.\n\nOutcome 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population will include patients admitted in King Faisal Specialist Hospital and Reseach Centre (KFSH\\&RC) Riyadh, Saudi Arabia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCriteria Include patients infected with the COVID19 (via positive PCR) aged ≥ 18 years with one of the following:\n\n* Hypertension\n* Coronary artery disease\n* Heart failure\n* Diabetes mellitus.\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04357535', 'briefTitle': 'Prognosis of Coronavirus Disease 2019 (COVID-19) Patients Receiving Receiving Antihypertensives', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Prognosis of SARS-Cov 2 Positive Patients Receiving Angiotensin Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Antagonists (ARBs)', 'orgStudyIdInfo': {'id': '2210061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Cohort', 'description': 'Patients enrolled in this study will have data collected from the beginning of their hospital stay until discharge.\n\nData collected will include:\n\n* Patient demographics (age, sex, weight, and height)\n* Indication for ACE-I, ARB therapy, duration and doses\n* Use of any a non ACE-I/ ARB sntihypertensive agents\n* Comorbidities, and COVID19 related markers: Including WBC, plateltes, ferritin, CRP, CK, and LD\n* CT scan reports\n* First positive COVID19 PCR\n* Admission to the intensive care unit (ICU) and data relating to ICU stay.', 'interventionNames': ['Drug: Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)']}], 'interventions': [{'name': 'Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)', 'type': 'DRUG', 'otherNames': ['ACE-I', 'ARB'], 'description': 'ACE-I and ARB are a class of blood pressure lowering medications used to manage hypertension.', 'armGroupLabels': ['Primary Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Centre', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Hakeam A Hakeam, MSPharm BCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Faisal Specialist Hospital and Research Centre (KFSH&RC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'On publication, according to the journal requirements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hakeam Abdulaziz Hakeam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Buraidah Central Hospital', 'class': 'OTHER_GOV'}, {'name': 'King Khalid University Hospital', 'class': 'OTHER'}, {'name': 'Princess Nourah Bint Abdulrahman University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Specialist, Surgery. Pharmaceutical Care Division, King Faisal Specialist Hospital & Research Centre. Adjunct Assistant Clinical Professor College of Medicine, Alfaisal University.', 'investigatorFullName': 'Hakeam Abdulaziz Hakeam', 'investigatorAffiliation': 'King Faisal Specialist Hospital & Research Center'}}}}