deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 6-arm NCT04447469

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

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

Sponsor: Kiniksa Pharmaceuticals International, plc

Conditions COVID
Interventions Placebo mavrilimumab
Updated 15 times since 2020 Last updated: Dec 27, 2024 Started: Jul 28, 2020 Primary completion: Nov 12, 2021 Completion: Jan 14, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04447469, this PHASE2/PHASE3 trial focuses on COVID and remains completed. Sponsored by Kiniksa Pharmaceuticals International, plc, it has been updated 15 times since 2020, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jan 2022 · 9 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE2/PHASE3

  4. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

  5. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

▶ Show 10 earlier versions

  1. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  2. Apr 2022 — Sep 2022 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not Recruiting → Completed

  3. Jan 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Apr 2021 — Jan 2022 [monthly]

    Recruiting PHASE2_PHASE3

  5. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2_PHASE3

  6. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  7. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2_PHASE3

  8. Sep 2020 — Nov 2020 [monthly]

    Recruiting PHASE2_PHASE3

  9. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting

  10. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kiniksa Pharmaceuticals International, plc
  • Kiniksa Pharmaceuticals, Ltd.
Data source: Kiniksa Pharmaceuticals International, plc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bellavista, Peru , Belo Horizonte, Brazil , Belém, Brazil , Bloemfontein, South Africa , Botucatu, Brazil , Bryn Mawr, United States , Campinas, Brazil , Cape Town, South Africa , Chicago, United States , Cincinnati, United States and 20 more locations