Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
Summary
Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
Official Title
A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation
Details
The Phase 2 portion of the study will evaluate the efficacy and safety of 2 dose levels of mavrilimumab relative to placebo (standard of care) in participants who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have x-ray/computerized tomography (CT) evidence of bilateral pneumonia, active or recent fever, and clinical laboratory results indicative of hyper-inflammation. The Phase 3 portion is intended to confirm Phase 2 efficacy and safety findings. In both Phase 2 and Phase 3, participants will be enrolled into 2 cohorts: Cohort 1 will include non-intubated, hospitalized participants who require supplemental oxygen to maintain oxygen saturation (SpO2) ≥ 92% (ie, "non-ventilated" participants); Cohort 2 will include hospitalized participants for whom mechanical ventilation was recently initiated (ie, "ventilated" participants). Following Screening, enrolled participants in each cohort will be randomized 1:1:1 to receive one of 2 mavrilimumab dose levels, or placebo as a single intravenous (IV) infusion (Day 1). Participants will undergo primary study assessments through Day 29 and will be followed for safety through Day 90.
Keywords
COVID COVID-19 pneumonia hyper-inflammation Inflammation Mavrilimumab
Eligibility
You can join if…
Open to people ages 18 years and up
- Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form
- Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
- Hospitalized for SARS-CoV-2
- Bilateral pneumonia on chest x-ray or computed tomography
- Active fever or recently documented fever within 72 hours prior to randomization
- Clinical laboratory results indicative of hyper-inflammation
- Cohort 1: Receiving any form of oxygenation or NIV to maintain SpO2 ≥ 92% and not-intubated (examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, or non-invasive positive pressure ventilation)
- Cohort 2: Recently ventilated with mechanical ventilation prior to randomization
You CAN'T join if...
- Onset of COVID-19 symptoms or positive COVID-19 test result > 14 days prior to randomization
- Hospitalized > 7 days prior to randomization
- Need for invasive mechanical ventilation (Only for Cohort 1)
- Need for ECMO
- Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial
- Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, cell-depleting biological therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-IL-6 receptor [eg, tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), COVID-19-immune plasma, or other immunosuppressant within 4 weeks prior to randomization
- corrected QT interval Fridericia's formula (QTcF) on Screening electrocardiogram (ECG) ≥450 ms
- Chronic or recent (within 7 days prior to randomization) corticosteroid use >10 mg/day
Locations
- UCLA Medical Center
accepting new patients
Los Angeles California 90095 United States - Sharp Health Care
accepting new patients
San Diego California 92110 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Kiniksa Pharmaceuticals, Ltd.
- ID
- NCT04447469
- Phase
- Phase 2/3
- Study Type
- Interventional
- Last Updated