UMIN-CTR Clinical Trial

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
Email	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
Email	yyamashi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Fukushima Daiichi Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052289