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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046519
Receipt No. R000053037
Scientific Title Thromboprophylaxis and clinical outcomes in patients with moderate COVID-19: A comparative study
Date of disclosure of the study information 2022/01/15
Last modified on 2022/01/02

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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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