UMIN-CTR Clinical Trial

Basic information
Public title	Thromboprophylaxis in patients with moderate COVID-19
Acronym	Thromboprophylaxis in COVID-19
Scientific Title	Thromboprophylaxis and clinical outcomes in patients with moderate COVID-19: A comparative study
Scientific Title:Acronym	Thromboprophylaxis and clinical outcomes in patients with moderate COVID-19: A comparative study : Thromboprophylaxis in COVID-19
Region	Africa

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

Objectives
Narrative objectives1	Use of(Enoxaparin) and Rivaroxaban in COVID-19
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(IMCU) duration, patients transferred to in (ICU),
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Enoxaparin for 3 weeks
Interventions/Control_2	Rivaroxaban for 3 weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Age: from 18 to 64 years Confirmed COVID-19 infection using RT-PCR
Key exclusion criteria	History of impairment of hemostasis
Target sample size	124

Research contact person
Name of lead principal investigator	1st name Asmaa Middle name S. Last name Mohamed
Organization	Faculty of Pharmacy, Port said University
Division name	Clinical Pharmacy Departement
Zip code	42534
Address	Port said, Egypt.
TEL	01066953443
Email	Asmaa.Mohamed@pharm.psu.edu.eg

Public contact
Name of contact person	1st name Hosam Middle name M. Last name Ahmad
Organization	Egypt Ministry of Health and population
Division name	Internal Medicine and biomedical chemistry
Zip code	61516
Address	Minia, Egypt
TEL	01000638308
Homepage URL
Email	hosam.refaei@yahoo.com

Sponsor
Institute	Port said University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Faculty of Pharmacy, Port said University
Address	Port said, Egypt.
Tel	066 3402344
Email	Asmaa.Mohamed@pharm.psu.edu.eg

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	2022 Year 01 Month 15 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 06 Month 01 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 02 Day
Last modified on	2022 Year 01 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053037

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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