Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial)

Ghati, Nirmal; Bhatnagar, Sushma; Mahendran, Manjit; Thakur, Abhishek; Prasad, Kshitij; Kumar, Devesh; Dwivedi, Tanima; Mani, Kalaivani; Tiwari, Pawan; Gupta, Ritu; Mohan, Anant; Saxena, Anita; Guleria, Randeep; Deepti, Siddharthan

doi:10.1186/s12879-022-07570-5

Table 3 Distribution of clinical outcomes in the study groups

From: Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial)

Outcome variables		Group A (Atorvastatin)	Group B (Aspirin)	Group C (Both)	Group D (None)	P Value
Primary outcome (Progression to WHO ordinal score ≥ 6)
Modified ITT (N = 882)	n/N (%)	7/221 (3.2)	3/221 (1.4)	8/221 (3.6)	7/219 (3.2)	0.46 ^a
Modified ITT (N = 882)	HR (95% CI), P	0.98 (0.34–2.79), 0.97	0.40 (0.10–1.54), 0.18	1.00 (0.36–2.77), 0.99	1	0.46 ^a
True ITT (N = 900)	n/N (%)	7/224 (3.1)	3/225 (1.3)	8/225 (3.6)	7/226 (3.1)	0.45 ^a
True ITT (N = 900)	HR (95% CI), P	0.86 (0.30–2.47), 0.78	0.37 (0.09–1.43), 0.15	0.81 (0.28–2.29), 0.68	1	0.45 ^a
Per protocol (N = 716)	n/N (%)	3/167 (1.8)	3/162 (1.8)	6/168 (3.6)	7/219 (3.2)	0.67^a
Per protocol (N = 716)	HR (95% CI), P	0.56 (0.14–2.16), 0.40	0.50 (0.13–1.96), 0.32	1.06 (0.36–3.16), 0.92	1	0.67^a
As per treatment received(N = 878)	n/N (%)	3/179 (1.7)	3/166 (1.8)	6/173 (3.5)	13/360 (3.6)	0.52^a
As per treatment received(N = 878)	HR (95% CI), P	0.45 (0.13–1.57), 0.21	0.46 (0.13–1.62), 0.23	0.95 (0.36–2.47), 0.89	1	0.52^a
Other clinical outcomes
Death
Modified ITT		7/221 (3.2)	3/221 (1.4)	8/221 (3.6)	7/219 (3.2)	0.46^a
True ITT		7/224 (3.1)	3/225 (1.3)	8/225 (3.6)	7/226 (3.1)	0.46 ^a
Per protocol		3/167 (1.8)	3/162 (1.8)	6/168 (3.6)	7/219 (3.2)	0.67^a
As per treatment received		3/179 (1.7)	3/166 (1.8)	6/173 (3.5)	13/360 (3.6)	0.52^a
Mechanical ventilation
Modified ITT		7/221 (3.1)	3/221 (1.3)	8/221 (3.6)	6/219 (2.7)	0.48^a
True ITT		7/224 (3.1)	3/225 (1.3)	8/225 (3.6)	6/226 (2.7)	0.47 ^a
Per protocol		3/167 (1.8)	3/162 (1.8)	6/168 (3.6)	6/219 (2.7)	0.72^a
As per treatment received		3/179 (1.7)	3/166 (1.8)	6/173 (3.5)	12/360 (3.3)	0.59^a
Shock
Modified ITT		5/221 (2.2)	1/221 (0.4)	6/221 (2.7)	6/219 (2.7)	0.19^a
True ITT		5/224 (2.2)	1/225 (0.4)	6/225 (2.7)	6/226 (2.7)	0.20 ^a
Per protocol		2/167 (1.2)	1/162 (0.6)	5/168 (3)	6/219 (2.7)	0.32^a
As per treatment received		2/179 (1.1)	1/166 (0.6)	5/173 (2.9)	10/360 (2.8)	0.27^a
Clinical deterioration^b
Modified ITT		27/221 (12.2)	26/221 (11.7)	20/221 (9.0)	22/219 (10.0)	0.68
True ITT		27/224 (12.1)	26/225 (11.6)	21/225 (9.3)	22/226 (9.7)	0.74
Per protocol		17/167 (10.2)	14/162 (8.6)	15/168 (8.9)	22/219 (10)	0.95
As per treatment received		19/179 (10.6)	14/166 (8.4)	15/173 (8.7)	46/360 (12.8)	0.35
Hospital admission duration (days)^γ
Modified ITT		9 (8–11)	9 (8–11)	9 (8–12)	9 (8–11)	0.85
True ITT		9 (8–12)	9 (8–11)	9 (8–12)	9 (7–11)	0.65
Per protocol		9 (8–11)	9 (8–11)	9 (8–11)	9 (8–11)	0.69
As per treatment received		9 (8–11)	9 (8–11)	9 (8–11)	9 (7–12)	0.54

ITT intension-to-treat, WHO World Health Organisation
^γMedian (p25-p75)
^aFisher exact test
^b≥ 1 increase in baseline WHO clinical improvement ordinal score

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