Studies of anti-GM-CSF in COVID-19 (as of July 5, 2020)

Mechanism of actionMoleculeTrialTrial nameDrugsPhasePrimary end point
TJ003234NCT04341116A Phase 1b/2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)TJ003234 (3 or 6 mg/kg, single infusion) vs placebo1b/2Proportion (%) of patients experiencing deterioration in clinical status (changes from baseline on day 14)
GimsilumabNCT04351243A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)Gimsilumab (high dose day 1 + gimsilumab low dose day 8) vs placebo2Mortality at day 43
Immunoglobulin G1 (IgG1) monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor (GM-CSF)LenzilumabNCT04351152A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 PneumoniaLenzilumab vs standard of care3Incidence of invasive mechanical ventilation and/or mortality (up to 28 days)
NamilumabEudraCT 2020-001684-89; ISRCTN40580903CATALYST - A randomised phase II proof of principle multi-arm multi-stage trial designed to guide the selection of interventions for phase III trials in hospitalised patients with COVID-19 infectionNamilumab vs gemtuzumab vs infliximab2SpO2, measured from /FiO2 randomization to day 14, hospital discharge, death
OtilimabNCT04376684A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19-Related DiseaseOtilimab as an IV infusion + standard of care vs placebo as IV infusion + standard of care2Proportion of participants alive and free of respiratory failure at day 28
IgG4 monoclonal antibody targeting GM-CSF receptor alphaMavrilimumabNCT04447469Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammationMavrilimumab vs placebo2/3Proportion of participants alive and without respiratory failure at day 15
NCT04399980Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation (RCT)Mavrilimumab vs placebo2Proportion of patients alive and off of oxygen at day 14
NCT04397497A Randomized, Double Blind, Placebo-controlled Trial of Mavrilimumab for Acute Respiratory Failure Due to COVID-19 Pneumonia With Hyper-inflammation (the COMBAT-19 Trial)Mavrilimumab (single-dose IV) vs placebo2Reduction in the dependency on oxygen supplementation (within day 14 of treatment)