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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | COVID-19 | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Age: from 18 to 64 years
Confirmed COVID-19 infection using RT-PCR |
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Key exclusion criteria | History of impairment of hemostasis
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Target sample size | 124 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Faculty of Pharmacy, Port said University | ||||||
Division name | Clinical Pharmacy Departement | ||||||
Zip code | 42534 | ||||||
Address | Port said, Egypt. | ||||||
TEL | 01066953443 | ||||||
Asmaa.Mohamed@pharm.psu.edu.eg |
Public contact | |||||||
Name of contact person |
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Organization | Egypt Ministry of Health and population | ||||||
Division name | Internal Medicine and biomedical chemistry | ||||||
Zip code | 61516 | ||||||
Address | Minia, Egypt | ||||||
TEL | 01000638308 | ||||||
Homepage URL | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |