A randomised trial of Mycobacterium w in critically ill patients with COVID-19: ARMY-1

https://doi.org/10.1183/23120541.00059-2021

NCT04347174-Patients were randomised 1:1 to receive either 0.3 mL.day(-1) of Mw intradermally or a matching placebo for three consecutive days. The primary outcome of the study was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The co-primary outcome was a change in SOFA (sequential organ failure assessment) score on days 7 and 14 compared to the baseline. We included 42 subjects (22 Mw, 20 placebo). On days 14 (OR 30.4 (95% CI 3.3-276.4)) and 21 (OR 14.9 (95% CI 1.8-128.4)), subjects in the Mw arm had a better clinical status distribution than placebo. There was no difference in the SOFA score change on days 7 and 14 between the two groups. We did not find any difference in the mortality, or other secondary outcomes. We observed no adverse events related to the use of Mw. The use of Mw results in better clinical status distribution on days 14 and 21 compared to placebo in critically ill patients with COVID-19.

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