TABLE 2

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

Mechanism of action	Molecule	Trial	Trial name	Drugs	Phase	Primary end point
	TJ003234	NCT04341116	A 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 placebo	1b/2	Proportion (%) of patients experiencing deterioration in clinical status (changes from baseline on day 14)
	Gimsilumab	NCT04351243	A 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 placebo	2	Mortality at day 43
Immunoglobulin G1 (IgG1) monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor (GM-CSF)	Lenzilumab	NCT04351152	A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia	Lenzilumab vs standard of care	3	Incidence of invasive mechanical ventilation and/or mortality (up to 28 days)
	Namilumab	EudraCT 2020-001684-89; ISRCTN40580903	CATALYST - 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 infection	Namilumab vs gemtuzumab vs infliximab	2	SpO₂, measured from /FiO₂ randomization to day 14, hospital discharge, death
	Otilimab	NCT04376684	A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19-Related Disease	Otilimab as an IV infusion + standard of care vs placebo as IV infusion + standard of care	2	Proportion of participants alive and free of respiratory failure at day 28

IgG4 monoclonal antibody targeting GM-CSF receptor alpha	Mavrilimumab	NCT04447469	Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation	Mavrilimumab vs placebo	2/3	Proportion of participants alive and without respiratory failure at day 15
		NCT04399980	Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation (RCT)	Mavrilimumab vs placebo	2	Proportion of patients alive and off of oxygen at day 14
		NCT04397497	A 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 placebo	2	Reduction in the dependency on oxygen supplementation (within day 14 of treatment)