Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation

  • STATUS
    Recruiting
  • End date
    Feb 17, 2022
  • participants needed
    588
  • sponsor
    Kiniksa Pharmaceuticals, Ltd.
Updated on 17 March 2021
pneumonia
fever
mechanical ventilation
chest x-ray
covid-19
SARS

Summary

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

Description

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) with x-ray/computed tomography (CT) evidence of bilateral pneumonia and active or recent signs of hyperinflammation (fever or 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.

Details
Condition COVID-19, COVID-19, Coronavirus Disease (COVID-19), COVID-19, COVID-19, Pathogen Infection Covid-19 Infection, *Corona Virus Infection, *COVID-19 Infection, Corona Virus Disease 2019(COVID-19), COVID-19, COVID-19, Treat and Prevent Covid-19 Infection, COVID-19, COVID-19 Infection, *COVID-19, COVID-19, Covid-19, COVID-19, COVID-19 Pneumonia, COVID-19, COVID-19, COVID-19, Covid-19, Pathogen Infection Covid-19 Infection, COVID-19, COVID-19, COVID-19, Use of Stem Cells for COVID-19 Treatment, COVID-19, COVID-19, Hospitalized Patients With Covid-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, COVID-19; Cardiovascular Diseases, Community-acquired Pneumonia, Influenza, COVID-19, Old Age, Usability, Visio Telephony, Confinement, Covid-19, COVID-19 Pneumonia, COVID-19 Pneumonia, Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), Old Age, Usability, Visio Telephony, Confinement, Covid-19, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, Severe Coronavirus Disease (COVID-19), Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, Anxiety Related to the COVID-19 Pandemic, Acute Respiratory Distress Syndrome Caused by COVID-19, Severe Coronavirus Disease (COVID-19), COVID-19 Pneumonia, *COVID-19 Infection, Severe Coronavirus Disease (COVID-19), COVID-19 by SARS-CoV-2 Infection
Treatment Placebo, mavrilimumab
Clinical Study IdentifierNCT04447469
SponsorKiniksa Pharmaceuticals, Ltd.
Last Modified on17 March 2021

Eligibility

Yes No Not Sure

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
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
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

Exclusion Criteria

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, 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
Corrected QT interval Fridericia's formula (QTcF) on Screening electrocardiogram (ECG) 500 ms
Enrolled in another investigational study of a medical intervention
Life expectancy less than 48 hours
Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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