UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042489 |
|---|---|
| Receipt number | 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 00:12:45 |
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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
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
dr.ptk@mail.ru
Sponsor or person
Institute
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Pulmonology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048499
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
