TABLE 1.
(A) Baseline characteristics of patients in the trial and (B) study interventions and co‐interventions during the trial period.
| A. Baseline characteristics of patients in the trial | |||
|---|---|---|---|
| Variable | Autoantibodies positive (N = 15) | Autoantibodies negative (N = 47) | p value |
| Age (years)—median (IQR) | 56 (44, 69) | 60 (47, 68) | 0.86* |
| Male sex—no. (%) | 12 (80.0) | 39 (83.0) | >0.99^^ |
| Body mass index (kg/m2)—mean ± SD | 28.4 ± 5.66 | 27.1 ± 5.90 | 0.46* |
| APACHE II‡ − mean ± SD | 24.1 ± 7.14 | 20.8 ± 10.53 | 0.26* |
| SOFA score, median (IQR) | 8.0 (7.0, 13.0) | 6.0 (4.0, 9.0) | 0.11^ |
| Karnofsky performance status score—median (IQR) | 90.0 (70.0, 100.0) | 90.0 (70.0, 100.0) | 0.97^ |
| Comorbidities—no. (%) | |||
| Any chronic comorbidity | 13 (86.7) | 39 (83.0) | >0.99^^ |
| Chronic cardiac disease | 5 (33.3) | 9 (19.1) | 0.30^^ |
| Chronic pulmonary disease | 1 (6.7) | 1 (2.1) | 0.43^^ |
| Chronic renal disease | 2 (13.3) | 16 (34.0) | 0.19^^ |
| Diabetes with chronic complications | 9 (60.0) | 15 (31.9) | 0.0519** |
| Location at time of randomization—no. (%) | |||
| Ward | 1 (6.7) | 16 (34.0) | 0.049^^ |
| ICU | 14 (93.3) | 31 (66.0) | |
| Randomization stratum—no. (%) | |||
| Mechanically ventilated | 10 (66.7) | 19 (40.4) | 0.08** |
| Not mechanically ventilated | 5 (33.3) | 28 (59.6) | |
| Interventions before randomization—no. (%) | |||
| Renal replacement therapy | 3 (20.0) | 18 (38.3) | 0.19** |
| Vasopressor therapy | 5 (33.3) | 8 (17.0) | 0.27^^ |
| Corticosteroids | 8 (53.3) | 15 (31.9) | 0.13** |
| B. Study interventions and co‐interventions during the trial period | |||
|---|---|---|---|
| Time of onset of symptoms to randomization, day, and median (IQR) | 7.0 (3.0, 11.0) | 8.0 (5.0, 12.0) | 0.33^ |
| Time of admission to randomization, day, and median (IQR) | 2.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | 0.64^ |
| Number of lopinavir‐ritonavir/placebo doses and median (IQR) | 28.0 (18.0, 28.0) | 24.0 (11.0, 28.0) | 0.08^ |
| Number of interferon‐β1b/placebo injection doses and median (IQR) | 7.0 (7.0, 7.0) | 6.0 (4.0, 7.0) | 0.04^ |
Note: *Plus–minus values are means ± SD. Continuous variables were compared between the two trial groups with the use of an independent *Student's t‑test or ^Mann–Whitney test, and categorical variables were compared with the use of a **chi‑square test or ^^Fisher's exact test. APACHE, acute physiology and chronic health evaluation; IQR, interquartile range; SOFA, sequential organ failure assessment.
*
Student's t‑test.
^
Mann–Whitney test.
**
Chi‑square test.
^^
Fisher's exact test.