TABLE 2.
Primary and secondary outcomes
| Parameter | Mw | Placebo | Total | p-value |
| Subjects n | 22 | 20 | 42 | |
| Primary outcome | ||||
| Clinical status (7-point scale) on day 14 | ||||
| 1: Not hospitalised with resumption of normal activities | 13 (59.1) | 8 (40) | 21 (50) | |
| 2: Not hospitalised, but unable to resume normal activities | ||||
| 3: Hospitalised, not requiring supplemental oxygen | 2 (9) | 4 (20) | 6 (14.2) | |
| 4: Hospitalised, requiring supplemental oxygen | 3 (13.6) | 3 (15) | 6 (14.2) | |
| 5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both | 1 (4.5) | 0 | 1 (2.4) | |
| 6: Hospitalised, requiring ECMO, invasive mechanical ventilation, or both | 1 (4.5) | 1 (5) | 2 (5) | |
| 7: Death | 2 (9) | 4 (20) | 6 (14.2) | |
| Difference in clinical status distribution versus placebo, OR (95% CI)# | 30.4 (3.3–276.4) | Reference | 0.002 | |
| Clinical status (7-point scale) on day 21 | ||||
| 1: Not hospitalised with resumption of normal activities | 16 (72.7) | 11 (55) | 27 (64.3) | |
| 2: Not hospitalised, but unable to resume normal activities | 1 (4.5) | 0 | 1 (2.4) | |
| 3: Hospitalised, not requiring supplemental oxygen | 0 | 3 (15) | 3 (7.1) | |
| 4: Hospitalised, requiring supplemental oxygen | 1 (4.5) | 0 | 1 (2.4) | |
| 5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both | 0 | 1 (5) | 1 (2.4) | |
| 6: Hospitalised, requiring ECMO (extracorporeal membrane oxygenation), invasive mechanical ventilation, or both | 2 (9.1) | 1 (5) | 3 (7.1) | |
| 7: Death | 2 (9.1) | 4 (20) | 4 (14.3) | |
| Difference in clinical status distribution versus placebo, OR (95% CI)# | 14.9 (1.8–128.4) | Reference | 0.013 | |
| Clinical status (7-point scale) on day 28 | ||||
| 1: Not hospitalised with resumption of normal activities | 16 (72.7) | 14 (70) | 30 (71.4) | |
| 2: Not hospitalised, but unable to resume normal activities | 1 (4.5) | 0 | 1 (2.4) | |
| 3: Hospitalised, not requiring supplemental oxygen | 0 | 1 (5) | 1 (2.4) | |
| 4: Hospitalised, requiring supplemental oxygen | 1 (4.5) | 0 | 1 (2.4) | |
| 5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both | 0 | 0 | 0 | |
| 6: Hospitalised, requiring ECMO, invasive mechanical ventilation, or both | 0 | 0 | 0 | |
| 7: Death | 4 (18.2) | 5 (25) | 9 (21.4) | |
| Difference in clinical status distribution versus placebo, OR (95% CI)# | 1.1 (0.2–4.5) | Reference | 0.95 | |
| Delta SOFA score at day 7 | 1 (0–2.5) | 1 (0–4) | 1 (0–3) | 0.52 |
| Delta SOFA score at day 14 | 0 (0–0) | 0 (0–1) | 0 (0–0.8) | 0.35 |
| Maximum SOFA score | 3 (2–4) | 3 (2–5) | 3 (2–4) | 0.51 |
| Secondary outcomes | ||||
| 28-day mortality¶ | 4 (18.1) | 5 (25) | 9 (21.4) | 0.69 |
| Time to reduction by one-point on seven-point ordinal scale days | 9 (5–10) | 7 (3–10) | 7 (4–10) | 0.52 |
| Time to reduction by two-point on seven-point ordinal scale days | 12 (11–14) | 11 (8–24) | 12 (10–15.3) | 0.85 |
| Days on vasopressor drug+ days | 0.7 (0.6–2.1) | 1 (0.4–2.1) | 0.8 (0.2–1.7) | 0.15 |
| Days on mechanical ventilation+ days | 2 (2.5–6.5) | 4 (1.3–9.3) | 3 (1–6.2) | 0.83 |
| ICU length of stay days | 8 (4–11) | 8 (4–13) | 8 (4–12) | 0.84 |
| Hospital length of stay days | 12 (9.5–16) | 12 (9–22) | 12 (9.3–17.8) | 0.92 |
| Time to PCR negativity days | 9 (7–15.5) | 7.5 (5–14) | 8.5 (6.3–14) | 0.53 |
Data are presented as median (first and third quartile) or n (%), unless otherwise stated. Mw: Mycobacterium w; ECMO: extracorporeal membrane oxygenation; SOFA: sequential organ failure assessment score; ICU: intensive care unit. #: OR and p-value for the Mw treatment arm comparison were estimated using the proportional odds assumption after adjustment for baseline disease severity and use of experimental therapies; ¶: 28-mortality calculated for 42 subjects (one patient in Mw arm withdrew consent after the first dose of the study drug and died on day 2, one patient in placebo arm left against medical advice and was assumed to have died); +: Mean (95% CI).