A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19

Area of Science:

• Immunology
• Virology
• Clinical Medicine

Background:

• Host genetics, including CCR5-Δ32 mutation, were hypothesized to influence COVID-19 severity.
• Leronlimab, a CCR5-specific antibody, was investigated for its potential impact on COVID-19.
• Understanding SARS-CoV-2 pathophysiology is crucial for developing effective treatments.

Purpose of the Study:

• To evaluate the efficacy of leronlimab in reducing disease symptoms in mild-to-moderate COVID-19 patients.
• To explore the impact of leronlimab on symptom scores and disease progression.

Main Methods:

• The TEMPEST trial was a randomized, double-blind, placebo-controlled study.
• Participants received subcutaneous leronlimab (700 mg) or placebo on days 0 and 7.
• The primary endpoint was the change in total symptom score at day 14.

Main Results:

• No significant difference in total symptom score change between leronlimab and placebo groups.
• A post hoc analysis showed improved National Early Warning Score 2 (NEWS2) in 50% of leronlimab recipients versus 20.8% of placebo recipients (p=0.0223).
• Adverse event rates were numerically lower in the leronlimab group (33.9%) compared to placebo (50.0%).

Conclusions:

• Leronlimab did not meet the primary endpoint for symptom improvement in mild-to-moderate COVID-19.
• Exploratory analysis suggests leronlimab may decrease the likelihood of disease progression.
• Further clinical trials are needed to confirm these findings.