UMIN-CTR Clinical Trial

Basic information
Public title	Association of calcium channel blocker use with COVID-19 clinical outcome: a metaanalysis
Acronym	Association of calcium channel blocker use with COVID-19 clinical outcome: a metaanalysis
Scientific Title	Association of calcium channel blocker use with COVID-19 clinical outcome: a metaanalysis
Scientific Title:Acronym	Association of calcium channel blocker use with COVID-19 clinical outcome: a metaanalysis
Region	Asia(except Japan)

Condition
Condition	COVID-19
Classification by specialty	Medicine in general Cardiology Infectious disease Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The interaction between COVID-19 and cardiovascular disease appears complex and bi-directional with cardiovascular disease increasing susceptibility to SARS-CoV-2 infection or COVID-19 severity and at the same time COVID-19 causing injury to the cardiovascular system in some patients. This meta-analysis aimed to determine the association of Calcium channel blocker use with COVID-19 clinical outcome
Basic objectives2	Others
Basic objectives -Others	This meta-analysis aimed to determine the association of Calcium channel blocker use with COVID-19 clinical outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Composite poor outcome of severity. mortality, need for ICU and mechanical ventilation
Key secondary outcomes	each percentage of primary outcome: severity. mortality, need for ICU and mechanical ventilation

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	all observational studies or trials that involving adult patients with COVID-19 that had any data of calcium chanel blocker use for comparison poor vs good outcome
Key exclusion criteria	missing required data, no data on CCB use, no outcome of interest, other than english language
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mochamad Middle name Last name Yusuf
Organization	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	628123543388
Email	yusuf_505@yahoo.com

Public contact
Name of contact person	1st name Eka Middle name Prasetya Budi Last name Mulia
Organization	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name	Department of Cardiology and Vascular Medicine
Zip code	60131
Address	Jl. Mayjen Prof. Dr. Moestopo 47
TEL	628562765365
Homepage URL	https://www.researchgate.net/profile/Eka_Mulia
Email	eka.prasetya.budi-2017@fk.unair.ac.id

Sponsor
Institute	Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
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, Indonesia
Address	Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel	62315501011
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 10 Month 11 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.dsx.2021.102210
Number of participants that the trial has enrolled	19298
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	Completed
Date of protocol fixation	2020 Year 10 Month 08 Day
Date of IRB	2020 Year 10 Month 09 Day
Anticipated trial start date	2020 Year 10 Month 11 Day
Last follow-up date	2020 Year 10 Month 11 Day
Date of closure to data entry	2020 Year 10 Month 31 Day
Date trial data considered complete	2020 Year 10 Month 31 Day
Date analysis concluded	2020 Year 11 Month 01 Day

Other
Other related information	A systematic search of all observational studies or trials that involving adult patients with COVID-19 that had any data of CCB use for comparison of poor vs good outcome was carried out using the PubMed, Science Direct, Scopus, ProQuest, and MedRxiv databases.

Management information
Registered date	2020 Year 10 Month 11 Day
Last modified on	2021 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048016