UMIN-CTR Clinical Trial

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