This was a randomized, double-blind, placebo-controlled, 29-day study to assess the efficacy and safety of axatilimab plus standard of care (SOC), compared with placebo plus SOC, in participants with respiratory signs and symptoms secondary to COVID-19.
Axatilimab (SNDX-6352) is a humanized immunoglobin G4 monoclonal antibody with high affinity against colony stimulating factor-1 receptor (CSF-1R) under investigation for the prevention or treatment of respiratory signs and symptoms secondary to COVID-19. This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of axatilimab as an add-on to SOC therapy in hospitalized participants with respiratory signs and symptoms secondary to COVID-19 compared to SOC treatment. Eligible participants were to be randomized in a 1:1 ratio to 1 of 2 treatment groups, active or control. All participants were to receive axatilimab or matching placebo intravenously (IV) as an add-on to SOC on Day 1, within 8 hours of randomization and on Day 15. Participants were to be followed for at least 28 days (+3 days) after the first dose of study intervention (Day 29). The primary objective of the study was to assess the proportion of participants alive and free of respiratory failure at Day 29.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1
HonorHealth
Scottsdale, Arizona, United States
Montefiore Medical Center
The Bronx, New York, United States
Count Of Participants Alive And Free Of Respiratory Failure At Day 29
Respiratory failure was defined by need for mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation \>6 liters oxygen/minute, or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making was driven solely by resource limitation.
Time frame: Day 29
Count Of Participants With Secondary Clinical Improvement Outcomes At Day 29
Participants achieving a ≥2 category improvement on a 7-point ordinal score relative to the baseline on Day 28 as collected on Day 29 are reported.
Time frame: Day 29
Time To Clinical Improvement
The time to clinical improvement is defined as a national early warning score of ≤2 maintained for 24 hours.
Time frame: Baseline through Day29
Change From Baseline At Day 29 In Oxygenation In Hospitalized Adults With Respiratory Signs And Symptoms Secondary To COVID-19 Treated With Axatilimab
The change from baseline at Day 29 or hospital discharge or death, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen is evaluated.
Time frame: Baseline, Day 29
Change From Baseline At Day 15 In Biomarkers Following Treatment With Axatilimab
The change from baseline at Day 15 in serum concentrations of interleukin 6 and c-reactive protein or hospital discharge or death is evaluated.
Time frame: Baseline, Day 15
Count Of Participants Experiencing Adverse Events And Serious Adverse Events
This outcome measure evaluates the safety and tolerability of axatilimab within the same population. A summary of all serious adverse events and other adverse events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
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Time frame: Baseline through Day 29
Count Of Participants Requiring Ventilation Support
Participants who required initiation of mechanical ventilation after study entry are analyzed.
Time frame: Baseline through Day 29
Count Of Participants Considered Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Free By Day 15
This outcome measure evaluates the antiviral effects of axatilimab in hospitalized adults by Day 15 or hospital discharge, whichever was sooner, with recently diagnosed SARS-CoV-2 infection.
Time frame: Day 15
Pharmacokinetics: Serum Concentration Of Axatilimab And Anti-drug Antibodies
The serum concentration of axatilimab and presence of anti-drug antibodies is evaluated.
Time frame: Day 29