Table 2.
Primary and secondary outcomes for patients included in the present analysis DisCoVeRy trial, according to disease severity at baselinea
| Overall (n = 583) |
Control (n = 148) |
Lopinavir/ritonavir (L/r) (n = 145) |
Lopinavir/ritonavir + interferon β-1a (L/r + IFN) (n = 145) |
Hydroxychloroquine (HCQ) (n = 145) |
L/r versus control effect measure (95%CI) | L/r + IFN versus control effect measure (95%CI) | HCQ versus control effect measure (95%CI) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Moderate (n = 372) | Severe (n = 211) | Moderate (n = 94) | Severe (n = 54) | Moderate (n = 94) | Severe (n = 51) | Moderate (n = 91) | Severe (n = 54) | Moderate (n = 93) | Severe (n = 52) | ||||
| Seven-point ordinal scale at day 15,n (%) | |||||||||||||
| 1. Not hospitalized, no limitations on activities | 84 (22.6%) | 3 (1.4%) | 23 (24.5%) | 1 (1.9%) | 21 (22.3%) | 1 (2.0%) | 20 (22.0%) | 0 (0.0%) | 20 (21.5%) | 1 (1.9%) | OR = 0.83 (0.55–1.26) (p = 0.39) | OR = 0.69 (0.45–1.04) (p = 0.08) | OR = 0.93 (0.62–1.41) (p = 0.75) |
| 2. Not hospitalized, limitation on activities | 146 (39.2%) | 16 (7.6%) | 41 (43.6%) | 6 (11.1%) | 36 (38.3%) | 2 (3.9%) | 35 (38.5%) | 1 (1.9%) | 34 (36.6%) | 7 (13.5%) | |||
| 3. Hospitalized, not requiring supplemental oxygen | 54 (14.5%) | 22 (10.4%) | 7 (7.4%) | 5 (9.3%) | 16 (17.0%) | 5 (9.8%) | 13 (14.3%) | 5 (9.3%) | 18 (19.4%) | 7 (13.5%) | |||
| 4. Hospitalized, requiring supplemental oxygen | 41 (11.0%) | 31 (14.7%) | 12 (12.8%) | 10 (18.5%) | 9 (9.6%) | 9 (17.6%) | 9 (9.9%) | 6 (11.1%) | 11 (11.8%) | 6 (11.5%) | |||
| 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices | 6 (1.6%) | 10 (4.7%) | 1 (1.1%) | 2 (3.7%) | 2 (2.1%) | 1 (2.0%) | 2 (2.2%) | 4 (7.4%) | 1 (1.1%) | 3 (5.8%) | |||
| 6. Hospitalized, on invasive mechanical ventilation or ECMO | 27 (7.3%) | 106 (50.2%) | 6 (6.4%) | 24 (44.4%) | 7 (7.4%) | 29 (56.9%) | 9 (9.9%) | 28 (51.9%) | 5 (5.4%) | 25 (48.1%) | |||
| 7. Death | 14 (3.8%) | 23 (10.9%) | 4 (4.3%) | 6 (11.1%) | 3 (3.2%) | 4 (7.8%) | 3 (3.3%) | 10 (18.5%) | 4 (4.3%) | 3 (5.8%) | |||
| 7-point ordinal scale at day 29, n (%) | |||||||||||||
| 1. Not hospitalized, no limitations on activities | 146 (39.2%) | 21 (10.0%) | 35 (37.2%) | 7 (13.0%) | 36 (38.3%) | 6 (11.8%) | 35 (38.5%) | 1 (1.9%) | 40 (43.0%) | 7 (13.5%) | OR = 0.93 (0.62–1.41) (p = 0.74) | OR = 0.76 (0.50–1.15) (p = 0.19) | OR = 1.16 (0.77–1.75) (p = 0.49) |
| 2. Not hospitalized, limitation on activities | 128 (34.4%) | 29 (13.7%) | 35 (37.2%) | 5 (9.3%) | 36 (38.3%) | 6 (11.8%) | 29 (31.9%) | 8 (14.8%) | 28 (30.1%) | 10 (19.2%) | |||
| 3. Hospitalized, not requiring supplemental oxygen | 45 (12.1%) | 45 (21.3%) | 12 (12.8%) | 15 (27.8%) | 10 (10.6%) | 9 (17.6%) | 11 (12.1%) | 10 (18.5%) | 12 (12.9%) | 11 (21.2%) | |||
| 4. Hospitalized, requiring supplemental oxygen | 14 (3.8%) | 19 (9.0%) | 4 (4.3%) | 6 (11.1%) | 4 (4.3%) | 4 (7.8%) | 4 (4.4%) | 6 (11.1%) | 2 (2.2%) | 3 (5.8%) | |||
| 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices | 5 (1.3%) | 10 (4.7%) | 2 (2.1%) | 1 (1.9%) | 1 (1.1%) | 2 (3.9%) | 1 (1.1%) | 3 (5.6%) | 1 (1.1%) | 4 (7.7%) | |||
| 6. Hospitalized, on invasive mechanical ventilation or ECMO | 14 (3.8%) | 52 (24.6%) | 1 (1.1%) | 13 (24.1%) | 3 (3.2%) | 14 (27.5%) | 6 (6.6%) | 13 (24.1%) | 4 (4.3%) | 12 (23.1%) | |||
| 7. Death | 20 (5.4%) | 35 (16.6%) | 5 (5.3%) | 7 (13.0%) | 4 (4.3%) | 10 (19.6%) | 5 (5.5%) | 13 (24.1%) | 6 (6.5%) | 5 (9.6%) | |||
| Time to improvement of 2 categories of the 7-point ordinal scale or hospital discharge within day 29 (days), median [IQR] | 10 [7-16] | 19 [14-29] | 9 [6-14] | 19 [10-29] | 11 [7-17] | 27 [14-29] | 10 [7-19] | 22 [15-29] | 10 [7-17] | 18 [13-29] | HR = 0.71 (0.54–0.93) (p = 0.012) | HR = 0.70 (0.54–0.92) (p = 0.009) | HR = 0.79 (0.61–1.03) (p = 0.08) |
| Time to National Early Warning Score ≤2 or hospital discharge within 29 days (days), median [IQR] | 9 [5-16] | 29 [17-29] | 8 [5-14] | 26 [15-29] | 9 [6-16] | 29 [22-29] | 9 [6-18] | 29 [19-29] | 9 [5-15] | 29 [16-29] | HR = 0.83 (0.63–1.09) (p = 0.17) | HR = 0.75 (0.56–0.99) (p = 0.046) | HR = 0.90 (0.68–1.18) (p = 0.45) |
| Time to hospital discharge within 29 days (days), median [IQR] | 10 [7-20] | 29 [19-29] | 9 [6-16] | 29 [19-29] | 12 [8-21] | 29 [24-29] | 11 [8-26] | 29 [28-29] | 11 [7-20] | 29 [16-29] | HR = 0.77 (0.58–1.02) (p = 0.07) | HR = 0.72 (0.54–0.96) (p = 0.026) | HR = 0.83 (0.62–1.10) (p = 0.20) |
| Oxygenation-free days until day 29 (days), median [IQR] | 22 [15-25] | 0 [0-13] | 22 [15-25] | 4 [0-14] | 22 [15-25] | 0 [0-12] | 22 [13-25] | 0 [0-6] | 22 [16-25] | 3 [0-15] | LSMD = –0.86 (–2.80 to 1.08) (p = 0.39) | LSMD = –1.68 (–3.66 to 0.29) (p = 0.10) | LSMD = 0.17 (–1.84 to 2.17) (p = 0.87) |
| Ventilator-free days until day 29 (days), median [IQR] | 29 [29-29] | 11 [0-20] | 29 [29-29] | 14 [0-22] | 29 [29-29] | 3 [0-19] | 29 [29-29] | 4 [0-16] | 29 [29-29] | 14 [1-22] | LSMD = –0.98 (–2.96 to 1.00) (p = 0.33) | LSMD = –2.01 (–4.03 to 0.00) (p = 0.05) | LSMD = 0.09 (–1.93 to 2.10) (p = 0.93) |
| Death within 28 days, no. (%) | 19 (5.1%) | 35 (16.6%) | 5 (5.3%) | 7 (13.0%) | 4 (4.3%) | 10 (19.6%) | 4 (4.4%) | 13 (24.1%) | 6 (6.5%) | 5 (9.6%) | OR = 1.24 (0.55–2.82) (p = 0.60) | OR = 1.51 (0.69–3.34) (p = 0.30) | OR = 0.93 (0.40–2.20) (p = 0.88) |
NP, nasopharyngeal; LRT, lower respiratory tract; OR, odds ratio; HR, hazard ratio; LSMD, least-square mean difference.
a
Analyses were stratified on the disease severity at baseline (moderate: seven-point ordinal scale 3 or 4; severe: seven-point ordinal scale 5 or 6), and adjusted effect measures are reported in the table.