NIPH Clinical Trials Search

JRCT ID: jRCT2031200443

Registered date:25/03/2021

REMAP-CAP:Randomized,Embedded,Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia Immune Modulation-2 Domain

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPatients with proven COVID-19 admitted to hospital, as moderate state
Date of first enrollment19/03/2021
Target sample size136
Countries of recruitmentUnited States of America,Japan
Study typeInterventional
Intervention(s)E5564 group : Intravenous administration is initiated with a first 26.24 mg loading dose (6.56 mg/h x 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h x 2 hours) at 12 hours, and twenty-six 6.56 mg maintenance doses (3.28 mg/h x 2 hours) one every 12 hours thereafter (total of 14 days). Placebo group : Placebo Eritoran (D5W only) should follow the same timing (total of 14 days).


Primary OutcomeOrdinal 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)
Secondary OutcomeAll-cause mortality at day 90 ICU outcomes - ICU mortality censored at 90 days - ICU LOS censored at 90 days - VFDs censored at 28 days - OFFDs censored at 28 days - Proportion of intubated participants who receive a tracheostomy censored at 28 days Hospital outcomes - Hospital LOS censored 90 days after enrollment - Destination at time of hospital discharge (characterized as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital); - Readmission to the index ICU during the index hospitalization in the 90 days following enrollment

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriaSARS-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) Given written informed consent to participate in the study from the patient (or legal representative)
Exclude criteria1) 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

Related Information


Public contact
Name Naho Shimodaira
Address Dainikyubiru 4F, Bakurocho 1-6-8, Nihonbashi, chuo-ku, Tokyo, Japan Tokyo Japan 103-0002
Telephone +81-3-6667-0250
Affiliation Clinical Service Inc.
Scientific contact
Name Shigeki Fujitani
Address 2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa, Japan Kanagawa Japan 216-8511
Telephone +81-44-977-8111
Affiliation St. Marianna University School of Medicine