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

JRCT ID: jRCT2031200443

Registered date:25/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with proven COVID-19 admitted to hospital, as moderate state
• Date of first enrollment: 19/03/2021
• Target sample size: 136
• Countries of recruitment: United States of America,Japan
• Study type: Interventional

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).

Outcome(s)

• Primary Outcome: 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)

Secondary Outcome

All-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 maximum: Not applicable
• Gender: Both

Include 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) Given written informed consent to participate in the study from the patient (or legal representative)

Exclude 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

Related Information

• Primary Sponsor: Fujitani Shigeki
• Source(s) of Monetary Support: Eisai Co., Ltd
• Secondary ID(s): NCT02735707