UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041430 |
|---|---|
| Receipt number | R000046347 |
| 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 |
| Date of disclosure of the study information | 2020/08/16 |
| Last modified on | 2020/08/16 10:11:02 |
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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
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
eka.rahayu.utami@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Universitas Airlangga
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046347
