Table 2.
Primary and secondary outcomes in modified intention to treat population according to treatment group.
| ATV |
DCV |
SOF + DCV |
Placebo |
Effect size |
p-value |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| ATV vs. Placebo |
DCV vs. Placebo |
SOF + DCV vs. Placebo |
ATV vs. Placebo | DCV vs. Placebo | SOF + DCV vs. Placebo | |||||
| n = 63 | n = 64 | n = 67 | n = 56 | (IC 95%) | (IC 95%) | (IC 95%) | ||||
| Primary outcome | ||||||||||
| 1. Decay rate (slope) of the. SARS-CoV-2 viral load logarithm from baseline to day 10; mean (95% CI) | −0.19 (−0.25 to −0.12) | −0.23 (−0.30 to −0.17) | −0.22 (−0.29 to −0.16) | −0.26 (−0.33 to −0.19) | 0.08 (−0.01 to 0.16) | 0.03 (−0.06 to 0.12) | 0.04 (−0.05 to 0.12) | 0.11 | 0.80 | 0.63 |
| Secondary outcomes | ||||||||||
| 1. Respiratory support free days in 15 days, mean (95% CI) | 6.19 (4.98–7.40) | 6.97 (5.68–8.27) | 6.79 (5.75–7.84) | 6.48 (5.21–7.68) | −0.28 (−1.96 to 1.49) | 0.50 (−1.24 to 2.21) | 0.32 (−1.25 to 1.94) | 0.75 | 0.58 | 0.69 |
| 2. 7-Stage ordinal scale for clinical outcomes on day 15, median [IQR] | 2.0 [1.0; 6.0] | 2.0 [1.0; 4.0] | 2.0 [1.5; 4.5] | 2.0 [1.0; 6.0] | 0.96 (0.46–1.74) | 0.95 (0.5–1.84) | 1.04 (0.5–1.8) | |||
| 3. 6-Stage ordinal scale for clinical outcomes on day 7, median [IQR] | 3.0 [1.0; 5.0] | 2.0 [1.0; 4.0] | 3.0 [1.0; 4.0] | 3.5 [2.0; 5.0] | 0.44 (0.35–1.27) | 0.59 (0.23–0.85) | 1.03 (0.31–1.1) | |||
| 4. 28-day mortality, n (%) | 8 (13%) | 10 (16%) | 9 (13%) | 8 (14%) | 0.77 (0.25–2.42) | 1.19 (0.40–3.62) | 0.77 (0.25–2.34) | |||
| 5. Days free from mechanical ventilation within 28 days, mean [SD] | 20.52 [11.82] | 22.09 [10.61] | 20.72 [11.99] | 20.36 [11.19] | 0.62 (−3.23 to 4.53) | 1.63 (−2.08 to 5.41) | 1.28 (−2.80 to 4.87) | |||
| 6. Days out of hospital in 28 days, mean [SD] | 13.44 [9.69] | 15.10 [9.25] | 13.29 [9.52] | 13.31 [9.10] | 0.61 (−3.03 to 3.95) | 1.30 (−1.80 to 4.48) | 0.61 (−2.91 to 3.76) | |||
| 7. Time to discharge, days, mean [SD] | 13.89 [8.01] | 11.75 [7.31] | 12.70 [8.15] | 12.98 [7.58] | 1.29 (−1.57 to 4.03) | −1.12 (−3.85 to 1.53) | −0.31 (−2.83 to 2.34) | |||
Data are n (%), mean [SD] median (IQR), n/N (%), mean (95% Confidence Interval).
Analysis were stratified by centre at random assignment and adjusted effect measure are reported. For primary outcome analysis, the missing data is imputed. It doesn't happen for secondary outcome analysis.
Percentages may not total 100 because of rounding.
ATV = Atazanavir, DCV = Daclatasvir, SOF + DCV = Sofosbuvir + Daclatasvir.