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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042489
Receipt No. R000048499
Scientific Title Combination therapy of Dexamethasone and Enoxoparin promotes SARS-CoV-2 pneumonia recovery
Date of disclosure of the study information 2020/11/18
Last modified on 2020/11/18

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Basic information
Public title Antiinflammatory and anticoagulative agents in COVID-19 pneumonia treatment
Acronym Treatment approaches in COVID-19 pneumonia
Scientific Title Combination therapy of Dexamethasone and Enoxoparin promotes SARS-CoV-2 pneumonia recovery
Scientific Title:Acronym Steroids and LMWH in SARS-CoV-2 pneumonia treatment
Region
Europe

Condition
Condition Completed
Classification by specialty
Medicine in general Pneumology Infectious disease
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 observational retrospective study of safety and efficasy of combination of Dexamethasone and Enoxoparin in SARS-CoV-2 pneumonia treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Dexamethasone therapy in SARS-CoV-2 patients significantly improved CT score and appear to decrease mortality rate.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria CT abnormalities (CT score 1-4), anticoagulant therapy, no contradiction for dexamethasone
Key exclusion criteria Dexamethasone intake for prior 6 month, anti-interleukin drugs admission
Target sample size 157

Research contact person
Name of lead principal investigator
1st name Vladimir
Middle name T.
Last name Ivaashkin
Organization Clinic of internal diseases propedeutics, gastroenterology, and hepatology, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Division name Internal Medicine
Zip code 119991
Address 8/2 Trubetskaya st., Moscow, Russia
TEL 0074992487128
Email kont07@yandex.ru

Public contact
Name of contact person
1st name Petr
Middle name E.
Last name Tkachenko
Organization Clinic of internal diseases propedeutics, gastroenterology, and hepatology, I.M. Sechenov First Mosc
Division name Internal Medicine
Zip code 119991
Address 8/2 Trubetskaya st., Moscow, Russia
TEL 0079166776451
Homepage URL
Email dr.ptk@mail.ru

Sponsor
Institute I.M. Sechenov First Moscow State Medical University (Sechenov University)





Pulmonology
Institute
Department

Funding Source
Organization I.M. Sechenov First Moscow State Medical University (Sechenov University)
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 I.M. Sechenov First Moscow State Medical University (Sechenov University)
Address 8/2 Trubetskaya st., Moscow, Russia
Tel 0079162841066
Email pak.tm_v@mail.ru

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
2020 Year 11 Month 18 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 157
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 Completed
Date of protocol fixation
2020 Year 04 Month 08 Day
Date of IRB
2020 Year 04 Month 01 Day
Anticipated trial start date
2020 Year 04 Month 08 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were monitored daily by physical examination and laboratory tests, CT scans throughout the study. The sex, age, comorbidities (coronary heart disease, arterial hypertension, chronic obstructive pulmonary disease, diabetes, malignancies were analyzed at admission. We also analyzed the period between fever onset and patient hospitalization.

Management information
Registered date
2020 Year 11 Month 18 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048499

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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