UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040598 |
|---|---|
| Receipt number | 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 13:27:39 |
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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
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
shingomatsumoto0606@gmail.com
Sponsor or person
Institute
Toho University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
