UMIN-CTR Clinical Trial

Basic information
Public title	Benefit and Harm of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker in COVID-19 Patients: A Review Protocol of Systematic Review and Meta-Analysis
Acronym	Benefit and Harm of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker in COVID-19 Patients: A Review Protocol of Systematic Review and Meta-Analysis
Scientific Title	Benefit and Harm of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker in COVID-19 Patients: A Review Protocol of Systematic Review and Meta-Analysis
Scientific Title:Acronym	Benefit and Harm of Angiotensin Converting Enzyme Inhibitor and Angiotensin Receptor Blocker in COVID-19 Patients: A Review Protocol of Systematic Review and Meta-Analysis
Region	Asia(except Japan)

Condition
Condition	There is a controversial debate regarding how to treat cardiovascular disease in COVID-19 confirmed patients. Ones documented that ACE inhibitor may increase risk of fatal COVID-19 by serving entry site for this virus, on contrary ones documented that ACEi and/or ARB may be beneficial for Acute Lung Injury and cardiovascular protection.
Classification by specialty	Cardiology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to determine the benefit and harm of ACEi and/or ARB therapy for COVID-19 patients.
Basic objectives2	Others
Basic objectives -Others	determine the benefit and harm of ACEi and/or ARB therapy for COVID-19 patients
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	cardiovascular mortality, all-cause mortality, severity, ARDS, need for ICU care, mechanical ventilation, hospitalization, cardiovascular injury, myocarditis, myocardial infarction, stroke, and heart failure
Key secondary outcomes	individual percentage of primary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	We will include retrospective clinical study that assessed the effect of ACEi-ARB treatment for COVID-19 patient.
Key exclusion criteria	The exclusion criteria are (1) non-English articles; (2) review, case-control studies, case reports, and case series; (3) studies without full-text articles; (4) studies that do not contain primary data in their published articles; and (5) unpublished records such as conference papers, theses, and patents.
Target sample size

Research contact person
Name of lead principal investigator	1st name Johanes Middle name Last name Nugroho
Organization	Faculty of Medicine, Universitas Airlangga
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	6282139090953
Email	j.nugroho.eko@fk.unair.ac.id

Public contact
Name of contact person	1st name Eka Middle name Rahayu Last name Utami
Organization	Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Airlangga, Dr. Soeto
TEL	6287701500013
Homepage URL
Email	eka.rahayu.utami@gmail.com

Sponsor
Institute	Faculty of Medicine, Universitas Airlangga
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Komite Etik Penelitian Kesehatan RSUD Dr Soetomo Surabaya
Address	Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel	0315501011
Email	kontak@rsudrsoetomo.jatimprov.go.id

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 15 Day
Date of IRB	2020 Year 07 Month 25 Day
Anticipated trial start date	2020 Year 07 Month 30 Day
Last follow-up date	2020 Year 08 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	meta-analysis

Management information
Registered date	2020 Year 08 Month 16 Day
Last modified on	2020 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046347