TABLE 2

Primary and secondary outcomes

ParameterMwPlaceboTotalp-value
Subjects n222042
Primary outcome
 Clinical status (7-point scale) on day 14
  1: Not hospitalised with resumption of normal activities13 (59.1)8 (40)21 (50)
  2: Not hospitalised, but unable to resume normal activities
  3: Hospitalised, not requiring supplemental oxygen2 (9)4 (20)6 (14.2)
  4: Hospitalised, requiring supplemental oxygen3 (13.6)3 (15)6 (14.2)
  5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive  mechanical ventilation, or both1 (4.5)01 (2.4)
  6: Hospitalised, requiring ECMO, invasive mechanical ventilation, or both1 (4.5)1 (5)2 (5)
  7: Death2 (9)4 (20)6 (14.2)
 Difference in clinical status distribution versus placebo, OR (95% CI)#30.4 (3.3–276.4)Reference0.002
 Clinical status (7-point scale) on day 21
  1: Not hospitalised with resumption of normal activities16 (72.7)11 (55)27 (64.3)
  2: Not hospitalised, but unable to resume normal activities1 (4.5)01 (2.4)
  3: Hospitalised, not requiring supplemental oxygen03 (15)3 (7.1)
  4: Hospitalised, requiring supplemental oxygen1 (4.5)01 (2.4)
  5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive  mechanical ventilation, or both01 (5)1 (2.4)
  6: Hospitalised, requiring ECMO (extracorporeal membrane oxygenation),  invasive mechanical ventilation, or both2 (9.1)1 (5)3 (7.1)
  7: Death2 (9.1)4 (20)4 (14.3)
 Difference in clinical status distribution versus placebo, OR (95% CI)#14.9 (1.8–128.4)Reference0.013
 Clinical status (7-point scale) on day 28
  1: Not hospitalised with resumption of normal activities16 (72.7)14 (70)30 (71.4)
  2: Not hospitalised, but unable to resume normal activities1 (4.5)01 (2.4)
  3: Hospitalised, not requiring supplemental oxygen01 (5)1 (2.4)
  4: Hospitalised, requiring supplemental oxygen1 (4.5)01 (2.4)
  5: Hospitalised, requiring nasal high-flow oxygen therapy, noninvasive  mechanical ventilation, or both000
  6: Hospitalised, requiring ECMO, invasive mechanical ventilation, or both000
  7: Death4 (18.2)5 (25)9 (21.4)
 Difference in clinical status distribution versus placebo, OR (95% CI)#1.1 (0.2–4.5)Reference0.95
  Delta SOFA score at day 71 (0–2.5)1 (0–4)1 (0–3)0.52
  Delta SOFA score at day 140 (0–0)0 (0–1)0 (0–0.8)0.35
  Maximum SOFA score3 (2–4)3 (2–5)3 (2–4)0.51
Secondary outcomes
 28-day mortality4 (18.1)5 (25)9 (21.4)0.69
 Time to reduction by one-point on seven-point ordinal scale days9 (5–10)7 (3–10)7 (4–10)0.52
 Time to reduction by two-point on seven-point ordinal scale days12 (11–14)11 (8–24)12 (10–15.3)0.85
 Days on vasopressor drug+ days0.7 (0.6–2.1)1 (0.4–2.1)0.8 (0.2–1.7)0.15
 Days on mechanical ventilation+ days2 (2.5–6.5)4 (1.3–9.3)3 (1–6.2)0.83
 ICU length of stay days8 (4–11)8 (4–13)8 (4–12)0.84
 Hospital length of stay days12 (9.5–16)12 (9–22)12 (9.3–17.8)0.92
 Time to PCR negativity days9 (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).