British journal of clinical pharmacology · 2026
Intravenous lanadelumab for the treatment of moderately ill COVID-19 patients.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Engel Job J, van Linge Christine, Wiersinga W Joost, Kouijzer Ilse J E, de Mast Quirijn, Hassing Robert-Jan, Huijbens Danique J H, Leavis Helen L, Schutgens Roger, Maas Coen, Roes Kit C B, van de Veerdonk Frank L, Brüggemann Roger
Аннотация
AIMS: Kallikrein-kinin system (KKS) dysregulation is hypothesized to play a pathogenetic role in COVID-19-associated pulmonary oedema. To investigate the efficacy and safety of intravenous lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, in COVID-19, we conducted a phase 2, open-label, randomized-controlled, proof-of-concept, interventional trial.
METHODS: We recruited 40 patients hospitalized with moderate COVID-19 and randomized them 1:1 to receive either standard-of-care (SoC) treatment or SoC plus intravenous lanadelumab (300 mg on days one and four). The primary outcome consisted of repeated measurements of supplemental oxygen (litres/minute) necessary to maintain a peripheral oxygen saturation (SpO2) ≥ 93%. Secondary outcomes included modified WHO-CPS scores, need for high-flow oxygen therapy or mechanical ventilation, admission to the intensive care unit, length of hospital stay and all-cause mortality over a 14-day period.
RESULTS: Sufficient endpoint data for the population were available for the first five days, but not for the previsioned 14-day endpoint. Consequently, analysis of the primary endpoint was based on the first five days of treatment. Within this timeframe, lanadelumab did not significantly affect supplemental oxygen volumes. Neither treatment nor interaction between treatment and time was a significant predictor of oxygen volumes in a linear mixed model (p = 0.49 and p = 0.15, respectively). None of the secondary outcomes was significantly affected by lanadelumab. Intravenous lanadelumab was well tolerated.
CONCLUSIONS: This exploratory study was evaluated using a shortened primary endpoint period. Lanadelumab showed no indication of benefit on oxygen needs or other clinical outcomes in patients with COVID-19. Lanadelumab was well tolerated throughout the trial.
METHODS: We recruited 40 patients hospitalized with moderate COVID-19 and randomized them 1:1 to receive either standard-of-care (SoC) treatment or SoC plus intravenous lanadelumab (300 mg on days one and four). The primary outcome consisted of repeated measurements of supplemental oxygen (litres/minute) necessary to maintain a peripheral oxygen saturation (SpO2) ≥ 93%. Secondary outcomes included modified WHO-CPS scores, need for high-flow oxygen therapy or mechanical ventilation, admission to the intensive care unit, length of hospital stay and all-cause mortality over a 14-day period.
RESULTS: Sufficient endpoint data for the population were available for the first five days, but not for the previsioned 14-day endpoint. Consequently, analysis of the primary endpoint was based on the first five days of treatment. Within this timeframe, lanadelumab did not significantly affect supplemental oxygen volumes. Neither treatment nor interaction between treatment and time was a significant predictor of oxygen volumes in a linear mixed model (p = 0.49 and p = 0.15, respectively). None of the secondary outcomes was significantly affected by lanadelumab. Intravenous lanadelumab was well tolerated.
CONCLUSIONS: This exploratory study was evaluated using a shortened primary endpoint period. Lanadelumab showed no indication of benefit on oxygen needs or other clinical outcomes in patients with COVID-19. Lanadelumab was well tolerated throughout the trial.