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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043369
Receipt No. R000049195
Scientific Title Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAIN
Date of disclosure of the study information 2021/02/18
Last modified on 2021/02/18

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Basic information
Public title Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAIN
Acronym Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAIN
Scientific Title Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAIN
Scientific Title:Acronym Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAIN
Region
Japan

Condition
Condition Patients with proven COVID-19 admitted to hospital, as moderate state
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this domain is to determine the effectiveness and safety of immune modulation therapy, Eritoran.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ordinal scale that is a composite end-point that comprises mortality during the acute hospital admission and the number of whole and part study days for which the patient is alive and not requiring organ failure support(Organ failure free days)
Key secondary outcomes 1)All-cause mortality (Time Frame: Day 90)

2) Pandemic outcome
World Health Organisation 8-point ordinal scale outcome

3) ICU outcomes
a. ICU Mortality censored at 90 days
b. ICU LOS censored at 90 days
c. Ventilator free days censored at 28 days
d. Organ failure free days densored at 28 days
e. Proportion of intubated participants who receive a tracheostomy censored at 28 days

4)Hospital outcome
a. Hospital length of stay censored 90 days after enrollment
b.Destination at time of hospital discharge.
(characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital)
c. Readmission to the index ICU during the index hospitalization in the 90 days following enrollment
All-cause mortality (Time Frame: 6 months)
d. Survival at 6 months after enrollment
e. HRQoL at 6 months after enrollment using the EQ5D-5L
f. Disability status measured at 6 months after enrollment using the WHODAS 2.0, 12-item
instrument



Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eritoran
Interventions/Control_2 Placebo
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria SARS-CoV-2 infection is confirmed by local microbiological testing.

1)Adult patients(>=20 years old) who have acute illness due to confirmed COVID infection in the moderate State, and admitted to hospital
2)
Key exclusion criteria 1)Healthcare-associated pneumonia:
a. known to have been an inpatient in any healthcare facility within the last 30 days
b. Resident of a nursing home or long-term care facility.
2)Death is deemed to be imminent and inevitable during the next 24 hours AND the patient and/or a treating team is not committed to full active treatment.
3)Expected to be discharged from hospital today or tomorrow
4)>=14 days while admitted to hospital with symptoms of COVID-19
5)Previous participation in this REMAP within the last 90 days
6)Has already received any dose of one or more of any form of immune modulators during this hospitalization
7)Is on long-term therapy or has been randomized in a trial evaluating an immune modulation agent for confirmed COVID-19 infection
8)The treating clinician believes that participation in the domain would not be in the best interests of the patient
9)Known active current or history of mycobacterial disease
10)Receiving a mean dose of >0.5 mg/kg prednisone or equivalent dose of another agent in the 7 days prior to eligibility assessment, except if used as a treatment for septic shock or severe COVID-19 disease
11)Known pregnancy or pregnancy status unknown in female of child-bearing age
12)Known immunosuppressive therapy
13)Ongoing breastfeeding or plan to breastfeed
14)Known hypersensitivity to active ingredient or any of the excipients
15)Chemotherapy or other cancer treatment for >= 3 months
16)Neutrophil count < 1000/mm^3 unless believed due to COVID-19
17)HIV-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes
18)EF < 35%
19)Known severe liver disease (Child C)
20)Ongoing or planned use of polymyxin B, hemofiltration, endotoxin removal devices,plasma exchange, in the absence of renal impairment
21)Known or estimated weight greater than 150 kg
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Shigeki
Middle name
Last name Fujitani
Organization St. Marianna University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan
TEL 044-977-8111
Email shigekifujitani@marianna-u.ac.jp

Public contact
Name of contact person
1st name Shigeki
Middle name
Last name Fujitani
Organization St. Marianna University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan
TEL 044-977-8111
Homepage URL https://www.remapcap.jp
Email shigekifujitani@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine

Department of Emergency and Critical Care Medicine,
Institute
Department

Funding Source
Organization Eisai Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine Institutional Review Board
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02735707
Org. issuing International ID_1 clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 02 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
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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 23 Day
Date of IRB
2021 Year 02 Month 12 Day
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 18 Day
Last modified on
2021 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049195

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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