Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. Immune Modulation-2 DOMAI
- Conditions
- Patients with proven COVID-19 admitted to hospital, as moderate state
- Registration Number
- JPRN-UMIN000043369
- Lead Sponsor
- St. Marianna University School of Medicine Department of Emergency and Critical Care Medicine,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 136
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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