Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
COVID
About this trial
This is an interventional treatment trial for COVID focused on measuring COVID-19, pneumonia, hyper-inflammation
Eligibility Criteria
Key Inclusion Criteria:
- 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. Consent must be performed per institutional regulations.
- Age of ≥ 18 years
- Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
- Hospitalized for SARS-CoV-2 (2019-nCoV)
- Bilateral pneumonia on chest x-ray or computed tomography
- Clinical laboratory results indicative of hyper-inflammation within 7 days prior to randomization
- Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and non-mechanically ventilated (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 beginning within 48 hours prior to randomization
Key Exclusion Criteria:
- Onset of COVID-19 symptoms > 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, non-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), or other immunosuppressant (except for corticosteroids) within 4 weeks prior to randomization. Medications that become standard of care for COVID-19 and/or receive emergency use authorization may be allowed after discussion with the medical monitor.
- If subject is receiving or has received hydroxychloroquine within 3 months prior to screening visit, a corrected QT interval by Federicia method (QTcF) on Screening electrocardiogram (ECG) ≥500ms is exclusionary. If subject has a pacemaker, this criterion does not apply.
- Enrolled in another investigational study of a medical intervention within 30 days prior to randomization. Participation in open label trials involving investigational treatments for COVID-19 may be allowed upon approval by the Sponsor.
- Life expectancy less than 48 hours, in the opinion of the Investigator
- Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity
Sites / Locations
- UCLA Medical Center
- SHARP Health Care
- Affinity Health
- Tulane University School of Medicine
- Allina Health System
- Mercy Clinic Hospitalists
- University of Cincinnati
- Bryn Mawr Hospital
- University of Texas Health Sciences
- Hospital Cardio Pulmonar
- Hospital Luxemburgo - Associação Mário Penna
- CPCLIN - Centro de Pesquisas Clínicas
- Hospital Bruno Born
- UPECLIN - Unidade de Pesquisa Clínica
- IPECC - Instituto de Pesquisa Clínica de Campinas
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
- Hospital Adventista de Belem
- IEP HGF - Instituto de Estudos e Pesquisas Clinicas do Ceará
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
- Hospital Alemão Oswaldo Cruz
- Clinica Las Condes
- Hospital Clinico Universidad de Chile
- Hospital Nacional Alberto Sabogal Sologuren
- Essalud - Hospital de Emergencias Grau
- Hospital Nacional Cayetano Heredia
- Clinica Providencia
- University of Cape Town - Lung Institute
- IATROS International
- Tiervlei Trial Center
- TASK Eden
- Into Research - Little Company of Mary Medical Center
- Limpopo Clinical Research Initiative
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
10 mg/kg (Cohort 1)
6 mg/kg (Cohort 1)
Placebo (Cohort 1)
10 mg/kg (Cohort 2)
6 mg/kg (Cohort 2)
Placebo (Cohort 2)
Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion
Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion
Non-mechanically ventilated participants administered placebo as a single IV infusion
Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion
Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion
Mechanically ventilated participants administered placebo as a single IV infusion