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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: 08 Jun 2020

At a glance

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

    • 08 Jun 2020 According to a Kiniksa Pharmaceuticals media release, data from this trial was presented at the European E-Congress of Rheumatology (EULAR) 2020
    • 08 Jun 2020 Results published in Kiniksa Pharmaceuticals media release.
    • 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.

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

Therapeutic efficacy

The results from clinical trial in patients with severe respiratory insufficiency associated with COVID-19 pneumonia and inflammation in 39 evaluable patients showed that at the 28-day follow-up period, mavrilimumab-treated patients experienced earlier and improved clinical outcomes than control-group patients, including earlier weaning from supplemental oxygen, shorter hospitalizations and no deaths. The data was evidenced by the magnitude of severe hypoxia and elevated inflammatory markers, such as C-reactive protein and interleukin-6. Mavrilimumab-treated patients exhibited 0% (n=0) incidence of death, relative to a 27% (n=7) death incidence viewed in control-group patients (p=0.046 for time to death). 8% (n = 1/13) of mavrilimumab-treated patients progressed to mechanical ventilation by day 28, compared to 35% (n = 9/26) of control-group patients who progressed to mechanical ventilation or died (p = 0.077). 100% (n = 13/13) of mavrilimumab-treated patients and 65% (n = 17/26) of control-group patients attained the clinical improvement endpoint (defined as improvement of = 2 categories on a 7-point scale for assessment of clinical status) by Day 28 (p=0.0001). Fever resolved in 91% (n = 10/11 febrile patients) of mavrilimumab-treated patients by day 14, compared to 61% (n=11/18 febrile patients) of control-group patients (p = 0.0093). Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status. Earlier results showed that, mavrilimumab-treated patients reached the endpoint earlier relative to control-group patients (median [95% CI]: 8.0 [5.0–11.0] days versus NE (not estimable) [11.0–NE], p = 0.001). Consequently, mavrilimumab-treated patients experienced a faster discharge from the hospital, as compared with the control-group patients (median [95% CI]: 10.0 [9.0–12.0] days vs. NE [12.0–NE], p=0.013). Eight% (n=1) and 35% (n=9) of mavrilimumab-treated and control group-treated patients received mechanical ventilation (p=0.077 for time to mechanical ventilation or death). Earlier results from seven COVID-2019 infections patients treated with mavrilimumab were consistent with the previous data. One of the 7 patients was electively intubated and subsequently returned to low-level supplemental oxygen. All 13 patients reported clinical improvment and 12 out of 13 patients returned home. Earlier data showed that within one to three days all six patients showed an early resolution of fever and improvement in oxygenation. None of the patients required mechanical ventilation [1] [2] [3] [4] .

Adverse events

Data from a clinical trial in COVID-2019 infections in 39 evaluable patients showed that Mavrilimumab displayed a well-tolerated safety profile in all patients, bereft of infusion reactions [1] [2] .

Publications

  1. Kiniksa Pharmaceuticals. Kiniksa Announces 28-Day Clinical Outcomes Data from Mavrilimumab Treatment Protocol in Severe COVID-19 Pneumonia and Active U.S. IND for Phase 2/3 Clinical Trial. 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
  3. 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

Authors

Author Total Publications First Author Last Author
Kiniksa Pharmaceuticals 3 3 3

Trial History

Event Date Event Type Comment
08 Jun 2020 Results According to a Kiniksa Pharmaceuticals media release, data from this trial was presented at the European E-Congress of Rheumatology (EULAR) 2020 Updated 10 Jun 2020
08 Jun 2020 Results Results published in Kiniksa Pharmaceuticals media release. Updated 10 Jun 2020
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 28-Day Clinical Outcomes Data from Mavrilimumab Treatment Protocol in Severe COVID-19 Pneumonia and Active U.S. IND for Phase 2/3 Clinical Trial. 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
  3. Kiniksa Pharmaceuticals. Kiniksa Reports First Quarter 2020 Financial Results and Highlights Recent Corporate and Pipeline Activity. Media-Rel 2020;.

    Media Release
  4. 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
  5. 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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