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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
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
 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
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
 Per protocol (N = 716) n/N (%) 3/167 (1.8) 3/162 (1.8) 6/168 (3.6) 7/219 (3.2) 0.67a
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
 As per treatment received(N = 878) n/N (%) 3/179 (1.7) 3/166 (1.8) 6/173 (3.5) 13/360 (3.6) 0.52a
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
Other clinical outcomes
 Death
  Modified ITT   7/221 (3.2) 3/221 (1.4) 8/221 (3.6) 7/219 (3.2) 0.46a
  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) 0.67a
  As per treatment received   3/179 (1.7) 3/166 (1.8) 6/173 (3.5) 13/360 (3.6) 0.52a
 Mechanical ventilation
  Modified ITT   7/221 (3.1) 3/221 (1.3) 8/221 (3.6) 6/219 (2.7) 0.48a
  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) 0.72a
  As per treatment received   3/179 (1.7) 3/166 (1.8) 6/173 (3.5) 12/360 (3.3) 0.59a
 Shock
  Modified ITT   5/221 (2.2) 1/221 (0.4) 6/221 (2.7) 6/219 (2.7) 0.19a
  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) 0.32a
  As per treatment received   2/179 (1.1) 1/166 (0.6) 5/173 (2.9) 10/360 (2.8) 0.27a
 Clinical deteriorationb
  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
  1. ITT intension-to-treat, WHO World Health Organisation 
  2. γMedian (p25-p75)
  3. aFisher exact test
  4. b≥ 1 increase in baseline WHO clinical improvement ordinal score