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

NCT04447469 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 814

Last updated 2025-01-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

mavrilimumab

anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G \[IgG4\])

OTHER

Placebo

matching placebo

Sponsors & Collaborators

  • Kiniksa Pharmaceuticals, Ltd.

    collaborator INDUSTRY

  • Kiniksa Pharmaceuticals International, plc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2021-11-12
Completion
2022-01-14
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • Peru
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447469 on ClinicalTrials.gov