Table 3.
Distribution of clinical outcomes in the study groups
| 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 | |
ITT intension-to-treat, WHO World Health Organisation
γMedian (p25-p75)
aFisher exact test
b≥ 1 increase in baseline WHO clinical improvement ordinal score