Table 1.
Baseline demographic and clinical characteristics of the ITT population.
| AXA1125 33.9 g BID (n = 21) | Placebo BID (n = 20) |
|
|---|---|---|
| Age, years | ||
| Mean (SD) | 43.6 (10.12) | 43.6 (7.8) |
| Range | 24–56 | 29–54 |
| Median (IQR) | 48.0 (37.0, 52.0) | (36.0, 51.0) |
| Sex, n (%) | ||
| Male | 6 (28.6) | 7 (35.0) |
| Female | 15 (71.4) | 13 (65.0) |
| Race, n (%) | ||
| White | 19 (90.5) | 18 (90.0) |
| South Asian | 2 (9.5) | 1 (5.0) |
| Other | 0 | 1 (5.0) |
| Body weight, kg | ||
| Mean (SD) | 77.2 (13.9) | 77.3 (17.1) |
| Range | 62–111 | 48–101 |
| Median (Q1,Q3) | 73.9 (66.2, 88.4) | (61.1, 92.7) |
| Body mass index, kg/m2 | ||
| Mean (SD) | 26.4 (4.32) | 26.4 (4.25) |
| Range | 20.9–34.8 | 18.7–33.7 |
| Median (Q1,Q3) | 25.0 (23.7, 28.1) | 26.6 (22.7, 29.7) |
| Duration of Long COVID, daysa | ||
| Mean (SD) | 488.9 (210.6) | 537.2 (173.0) |
| Range | 123–762 | 99–795 |
| Median (Q1,Q3) | 527 (385.0, 675.0) | 525.5 (429.5, 694.0) |
| 6-MWT distance, observed:predicted, % | ||
| Mean (SD) | 82.4 (19.6) | 86.8 (17.3) |
| Range | 48.0–115.5 | 57.9–118.7 |
| Median (Q1,Q3) | 83.4 (66.8, 100.0) | 85.4 (73.4, 97.7) |
| CFQ-11 total fatigue (bimodal) scoreb | ||
| Mean (SD) | 10.48 (1.21) | 10.50 (0.89) |
| Range | 6–11 | 8–11 |
| Median (Q1,Q3) | 11 (11, 11) | 11 (10, 11) |
| CFQ-11 physical fatigue (bimodal) scoreb | ||
| Mean (SD) | 6.71 (0.78) | 6.85 (0.49) |
| Range | 4–7 | 5–7 |
| Median (Q1,Q3) | 7 (7, 7) | 7 (7, 7) |
| CFQ-11 mental fatigue (bimodal) scoreb | ||
| Mean (SD) | 3.76 (0.54) | 3.65 (0.75) |
| Range | 2–4 | 1–4 |
| Median (Q1,Q3) | 4.0 (4.0, 4.0) | 4.0 (3.5, 4.0) |
| CFQ-11 total fatigue (Likert) scoreb | ||
| Mean (SD) | 26.24 (3.59) | 28.05 (2.96) |
| Range | 18.0, 32.0 | 22.0, 32.0 |
| Median (Q1,Q3) | 26.00 (24.0, 28.0) | (28.0 (25.5, 31.0) |
| CFQ-11 physical fatigue (Likert) scoreb | ||
| Mean (SD) | 17.29 (2.54) | 18.95 (1.70) |
| Range | 10.0, 21.0 | 14.0, 21.0 |
| Median (Q1,Q3) | 17.0 (16.0, 19.0) | 19.5 (18.0, 21.0) |
| CFQ-11 mental fatigue (Likert) scoreb | ||
| Mean (SD) | 8.95 (1.56) | 9.10 (1.97) |
| Range | 6.0, 12.0 | 5.0, 12.0 |
| Median (Q1,Q3) | 8.00 (8.0, 10.0) | 8.5 (8.0, 11.0) |
BID, twice daily; CFQ-11, Chalder Fatigue Questionnaire, 11-item; SE, standard error.
a
Time from initial COVID-19 diagnosis to randomization to study treatment.
b
Pre-exercise fatigue.