Efficacy and safety of intravenous imatinib in COVID-19 ARDS: a randomized, double-blind, placebo-controlled clinical trial

Atmowihardjo, Leila N.; Schippers, Job R.; Duijvelaar, Erik; Bartelink, Imke H.; Bet, Pierre M.; Swart, Noortje E. L.; van Rein, Nienke; Purdy, Keith; Cavalla, David; McElroy, Andrew; Fritchley, Sarah; Vonk Noordegraaf, Anton; Endeman, Henrik; van Velzen, Patricia; Koopmans, Matty; Bogaard, Harm Jan; Heunks, Leo; Juffermans, Nicole; Schultz, Marcus J.; Tuinman, Pieter R.; Bos, Lieuwe D. J.; Aman, Jurjan

doi:10.1186/s13054-023-04516-4

Critical Care

Table 5 Treatment-emergent adverse and serious adverse events, stratified by treatment group

From: Efficacy and safety of intravenous imatinib in COVID-19 ARDS: a randomized, double-blind, placebo-controlled clinical trial

	AEs			SAEs
	Placebo n = 32	Imatinib n = 32	Total n = 64	Placebo n = 32	Imatinib n = 32	Total n = 64
Any treatment-emergent adverse events, n (%)	16 (50)	18 (56)	34 (53)	11 (34)	16 (50)	27 (42)
Anemia	0 (0)	0 (0)	0 (0)	2 (6)	1 (3)	3 (5)
Fatal outcome*, n (%)	0 (0)	0 (0)	0 (0)	8 (25)	10 (31)	18 (28)
Respiratory disorders
Bacterial pneumonia, n (%)	4 (13)	0 (0)	4 (6)	0 (0)	0 (0)	0 (0)
Viral pneumonia (herpes), n (%)	1 (3)	0 (0)	1 (2)	0 (0)	0 (0)	0 (0)
Aspiration pneumonia, n (%)	1 (3)	0 (0)	1 (2)	0 (0)	0 (0)	0 (0)
Fungal pneumonia, n (%)	2 (6)	3 (9)	5 (7.8)	1 (3)	0 (0)	1 (2)
Pneumonia unknown pathogen, n (%)	1 (3)	1 (3)	2 (3)	0 (0)	0 (0)	0 (0)
Respiratory failure, n (%)^†	1 (3)	0 (0)	1 (2)	4 (13)	11 (34)	16 (23)
Pneumothorax, n (%)	0 (0)	1 (3)	1 (2)	0 (0)	0 (0)	0 (0)
Pulmonary embolism, n (%)	3 (9)	6 (19)	9 (14)	0 (0)	0 (0)	0 (0)
Laryngeal edema, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (3)	1 (2)
Infections
Bacteremia, n (%)	3 (9)	5 (16)	8 (3)	0 (0)	0 (0)	0 (0)
Infection of unknown origin, n (%)	1 (3)	4 (13)	5 (8)	0 (0)	0 (0)	0 (0)
Sepsis, n (%)	0 (0)	1 (3)	1 (2)	0 (0)	0 (0)	0 (0)
Septic shock, n (%)	0 (0)	0 (0)	0 (0)	4 (13)	2 (6)	6 (9)
Ischemic stroke, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	0 (0)	1 (2)
Vascular
Arterial thrombosis, n (%)	0 (0)	1 (3)	1 (2)	0 (0)	0 (0)	0 (0)
Retroperitoneal hemorrhage, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	0 (0)	1 (2)
Cardiac disorders
Hyperkaliemia-induced cardiac arrest, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	0 (0)	1 (2)
Life-threatening arrhythmia, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (3)	1 (2)
Right ventricular failure, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (3)	1 (2)
Renal replacement therapy initiation, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	4 (13)	5 (8)
Muscle necrosis, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	0 (0)	1 (2)
Severe dyskinesia, n (%)	0 (0)	0 (0)	0 (0)	1 (3)	0 (0)	1 (2)
Skin rash, n (%)	1 (3)	1 (3)	2 (3)	0 (0)	0 (0)	0 (0)

Table summarizing the occurrence of adverse and serious treatment-emergent adverse events and the frequency of fatal outcomes of patients treated with imatinib or placebo (n = 64)
AEs adverse events; SAEs serious adverse events
^*7 deaths were reported beyond study day 28 in adherence with the CT3 guidelines of reporting adverse events in medicinal studies with human subjects. ^†4 cases of respiratory failure were reported beyond study day 28 (4 in the imatinib group, 0 in the placebo group)

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