At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 814 enrolled
Drug / intervention
mavrilimumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating mavrilimumab and Placebo for COVID. Completed, enrolled 814 participants across 32 sites in 5 countries.
Detailed Summary
Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID
CountriesBrazil, Chile, Peru, South Africa, United States
CollaboratorsKiniksa Pharmaceuticals, Ltd.
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJul 2020
Primary CompletionNov 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJun 25, 2020
Enrollment StartJul 28, 2020
Primary CompletionNov 12, 2021
Study CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.0 years ago
Interventions
mavrilimumabdrug
anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G \[IgG4\])
Placeboother
matching placebo