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A prospective, interventional, single-active-arm, single-center pilot study of mavrilimumab in patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation

Trial Profile

A prospective, interventional, single-active-arm, single-center pilot study of mavrilimumab in patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 May 2020

At a glance

  • Drugs Mavrilimumab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 29 May 2020 According to a Kiniksa Pharmaceuticals media release, data from this study will be presented at the at the European E-Congress of Rheumatology (EULAR) 2020.
    • 11 May 2020 Results published in the Kiniksa Pharmaceuticals Media Release
    • 28 Apr 2020 Results of additional 7 non-mechanically ventilated patients with COVID-19 pneumonia and hyperinflammation published in Kiniksa Pharmaceuticals Financial media release.

Trial Overview

Purpose

This single-active-arm, single-center pilot study aimed to assess the safety, tolerability and efficacy of mavrilimumab for the treatment of patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control group.

The objective of this protocol was to evaluate if mavrilimumab in addition to standard management could improve clinical outcomes in patients with COVID-19 pneumonia and hyperinflammation. A control-group was assembled consisting of contemporaneous patients receiving local standard of care and matched for age, sex, comorbidities, baseline inflammatory markers and respiratory dysfunction. Per standard of care of the hospital, all patients received on admission medical treatment with hydroxychloroquine, azithromycin, and lopinavir/ritonavir as well as respiratory support with supplemental oxygen and/or non-invasive ventilation with continuous positive airway pressure.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Actual: 13

  • Sex not stated

Patient Inclusion Criteria

Patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation

Trial Details

Organisations

  • Affiliations Kiniksa Pharmaceuticals

Trial Dates

Other Details

  • Design open; prospective
  • Phase of Trial Phase I
  • Location Italy
  • Focus Adverse reactions; Therapeutic Use

Interventions

Drugs Route Formulation
MavrilimumabPrimary Drug Intravenous
-

mavrilimumab

Results

Publications

  1. Kiniksa Pharmaceuticals. Kiniksa Announces Early Evidence of Treatment Response with Mavrilimumab in 6 Patients with Severe COVID-19 Pneumonia and Hyperinflammation. Media-Rel 2020;.

    Media Release
  2. Kiniksa Pharmaceuticals. Kiniksa Reports Data for Mavrilimumab in COVID-19 Pneumonia and Hyperinflammation and for Vixarelimab in Diseases Characterized by Chronic Pruritus. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Kiniksa Pharmaceuticals 2 2 2

Trial History

Event Date Event Type Comment
29 May 2020 Other trial event According to a Kiniksa Pharmaceuticals media release, data from this study will be presented at the at the European E-Congress of Rheumatology (EULAR) 2020. Updated 05 Jun 2020
11 May 2020 Results Results published in the Kiniksa Pharmaceuticals Media Release Updated 18 May 2020
28 Apr 2020 Results Results of additional 7 non-mechanically ventilated patients with COVID-19 pneumonia and hyperinflammation published in Kiniksa Pharmaceuticals Financial media release. Updated 04 May 2020
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020
31 Mar 2020 Other trial event According to a Kiniksa Pharmaceuticals media release, this trial protocol was conducted by Professor Lorenzo Dagna, MD, FACP and directed by Professor Alberto Zangrillo (Universita Vita-Salute San Raffaele, Milan, Italy). Updated 07 Apr 2020
31 Mar 2020 Results Results published in the Media Release Updated 07 Apr 2020

References

  1. Kiniksa Pharmaceuticals. Kiniksa Announces Early Evidence of Treatment Response with Mavrilimumab in 6 Patients with Severe COVID-19 Pneumonia and Hyperinflammation. Media-Rel 2020;.

    Media Release
  2. Kiniksa Pharmaceuticals. Kiniksa Reports First Quarter 2020 Financial Results and Highlights Recent Corporate and Pipeline Activity. Media-Rel 2020;.

    Media Release
  3. Kiniksa Pharmaceuticals. Kiniksa Reports Data for Mavrilimumab in COVID-19 Pneumonia and Hyperinflammation and for Vixarelimab in Diseases Characterized by Chronic Pruritus. Media-Rel 2020;.

    Media Release
  4. Kiniksa Pharmaceuticals. Kiniksa Announces Upcoming Presentation on Mavrilimumab in COVID-19 Pneumonia and Hyperinflammation at the European E-Congress of Rheumatology 2020. Media-Rel 2020;.

    Media Release
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