UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045800 |
|---|---|
| Receipt number | R000052289 |
| Scientific Title | Thrombosis and Anticoagulation Therapy in Patients with COVID-19 in Japan Study |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2022/04/18 15:38:25 |
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Basic information
Public title
Thrombosis and Anticoagulation Therapy in Patients with COVID-19 in Japan Study
Acronym
CLOT-COVID Study
Scientific Title
Thrombosis and Anticoagulation Therapy in Patients with COVID-19 in Japan Study
Scientific Title:Acronym
CLOT-COVID Study
Region
| Japan |
Condition
Condition
Coronavirus disease 2019: COVID-19, severe acute respiratory syndrome coronavirus 2: SARS-CoV-2, Thrombosis
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The coronavirus disease 2019 (COVID-19) has become a huge threat all over the world as a pandemic, which also could cause thrombosis including venous thromboembolism (VTE). Based on the concept of a high risk for thrombosis occurrence in patients with COVID-19, there could be a potential benefit of anticoagulation therapy for the primary prevention of thrombosis and treatment for COVID-19. However, the optimal strategies for the prevention of thrombosis and anticoagulation therapy in COVID-19 still remain unknown. Additionally, ethnic differences may have notable implications in the presentation of thrombosis. Unfortunately, there is a scarcity of data on current status of thrombosis and anticoagulation therapy in patients with COVID-19 in Japan. Thus, we are going to conduct the observational study to reveal the current status of thrombosis and anticoagulation therapy in patients with COVID-19 in Japan.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of thrombosis during the hospitalization
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to the hospital during the study period
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ogawa |
Organization
Fukushima Daiichi Hospital
Division name
Department of Cardiovascular Surgery
Zip code
960-8251
Address
16-2 Kitasawamata Nariide, Fukushima City, Fukushima Prefecture
TEL
024-557-5111
tomo-ogawa@msb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4254
Homepage URL
yyamashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Fukushima Daiichi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Fukushima Daiichi Hospital
Address
16-2 Kitasawamata Nariide, Fukushima City, Fukushima Prefecture
Tel
024-557-5111
tomo-ogawa@msb.biglobe.ne.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
福島県立医科大学
兵庫県立尼崎総合医療センター
北海道大学病院
横須賀市立うわまち病院
京都大学医学部附属病院
三重大学医学部附属病院
JCHO東京新宿メディカルセンター
横浜南共済病院
長崎大学大学院医歯薬学総合研究科
浜松医療センター
筑波メディカルセンター病院
東邦大学医療センター大橋病院
大阪市立大学大学院医学研究科
東北大学病院
四国こどもとおとなの医療センター 総合周産期センター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35430141/
Number of participants that the trial has enrolled
2894
Results
In the present large-scale observational study, pharmacological thromboprophylaxis for hospitalized patients with COVID-19 was common especially in patients with severe COVID-19, and management strategies varied widely across the participating centers. The overall incidence of thrombosis was substantially low with an increased incidence according to the severity of the COVID-19.
Results date posted
| 2022 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 05 | Day |
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
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 08 | Day |
Other
Other related information
https://pubmed.ncbi.nlm.nih.gov/35430141/
Management information
Registered date
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052289
