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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000040598
Receipt No. R000046132
Scientific Title Clinical Outcomes of COVID-19 Infection in Hospitalized Patients with Cardiovascular Diseases and/or Risk Factors: CLAVIS-COVID
Date of disclosure of the study information 2020/06/01
Last modified on 2021/06/01

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Basic information
Public title Clinical Outcomes of COVID-19 Infection in Hospitalized Patients with Cardiovascular Diseases and/or Risk Factors: CLAVIS-COVID
Acronym CLAVIS-COVID
Scientific Title Clinical Outcomes of COVID-19 Infection in Hospitalized Patients with Cardiovascular Diseases and/or Risk Factors: CLAVIS-COVID
Scientific Title:Acronym CLAVIS-COVID
Region
Japan

Condition
Condition COVID-19, Cadiovascular Diseases (CVD)
Classification by specialty
Cardiology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate impact of CVD and risk factors in patients with COVID-19.
Basic objectives2 Others
Basic objectives -Others To investigate (1) differences of in-hospital outcomes between COVID-19 patients with and without CVD and (2) predictors of in-hospital mortality in patients with COVID-19 and CVD.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In-hospital death
Key secondary outcomes 1. Duration of hospitalization
2. Length of stay in ICU
3. Arrhythmia (AF/AFL, AVB, VT, VF)
4. Use of NPPV or mechanical ventilation in ARDS
5. In-hospital cardiovascular death

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Hospitalized patients with COVID-19 and preexisting CVD and/or risk factors.
2. Patients with new-onset CVD on admission and/or during hospitalization.
Key exclusion criteria 1. Under 20 years old.
2. Refusal to participate.
3. The cases considered inappropriate.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Shigo
Middle name
Last name Matsumoto
Organization Toho University Faculty of Medicine
Division name Division of Cardiovascular Medicine
Zip code 143-8541
Address 6-11-1 Omorinishi, Otaku, Tokyo, Japan
TEL +81337624151
Email shingomatsumoto0606@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Matsumoto
Organization Toho University Faculty of Medicine
Division name Division of Cardiovascular Medicine
Zip code 143-8541
Address 6-11-1 Omorinishi, Otaku, Tokyo, Japan
TEL +81337624151
Homepage URL
Email shingomatsumoto0606@gmail.com

Sponsor
Institute Toho University Faculty of Medicine
Institute
Department

Funding Source
Organization Toho University Faculty of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Toho University Faculty of Medicine
Address 6-11-1 Omorinishi, Otaku, Tokyo, Japan
Tel +81337624151
Email omori.rinri@ext.toho-u.ac.jp

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 06 Month 01 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 Main results already published
Date of protocol fixation
2020 Year 05 Month 18 Day
Date of IRB
2020 Year 05 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study enrolling the hospitalized COVID-19 patients with CVD and/or risk factors between January 1, 2020 and May 31, 2020.

Management information
Registered date
2020 Year 05 Month 31 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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