UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043369 |
|---|---|
| Receipt number | 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 | 2021/09/27 18:52:01 |
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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) 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) A documented consent is obtained from a patient or authorized individual.
Key exclusion criteria
1)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.
2)Expected to be discharged from hospital today or tomorrow
3)>=14 days while admitted to hospital with symptoms of COVID-19
4)Previous participation in this REMAP within the last 90 days
5)Has already received any dose of one or more of any form of immune modulators during this hospitalization
6)Is on long-term therapy or has been randomized in a trial evaluating an immune modulation agent for confirmed COVID-19 infection
7)The treating clinician believes that participation in the domain would not be in the best interests of the patient
8)Known active current or history of mycobacterial disease
9)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
10)Known pregnancy or pregnancy status unknown in female of child-bearing age
11)Known immunosuppressive therapy
12)Ongoing breastfeeding or plan to breastfeed
13)Known hypersensitivity to active ingredient or any of the excipients
14)Chemotherapy or other cancer treatment for >= 3 months
15)Neutrophil count < 1000/mm^3 unless believed due to COVID-19
16)HIV-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes
17)EF < 35%
18)Known severe liver disease (Child C)
19)Ongoing or planned use of polymyxin B, hemofiltration, endotoxin removal devices,plasma exchange, in the absence of renal impairment
20)Known or estimated weight greater than 150 kg
Target sample size
136
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
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
shigekifujitani@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Department of Emergency and Critical Care Medicine,
Institute
Department
Personal name
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
kanna.miyazaki@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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 19 | 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
the same registry transferred to jRCT
Management information
Registered date
| 2021 | Year | 02 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049195
| Research Plan | |
|---|---|
| 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 |
