TY - JOUR T1 - A randomised trial of <em>Mycobacterium w</em> in critically ill patients with COVID-19: ARMY-1 JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00059-2021 VL - 7 IS - 2 SP - 00059-2021 AU - Inderpaul Singh Sehgal AU - Randeep Guleria AU - Sarman Singh AU - Mohammad Sabah Siddiqui AU - Ritesh Agarwal A2 - , Y1 - 2021/04/01 UR - http://openres.ersjournals.com/content/7/2/00059-2021.abstract N2 - Purpose We investigated whether Mycobacterium w (Mw), an immunomodulator, would improve clinical outcomes in coronavirus disease 2019 (COVID-19).Methods We conducted an exploratory, randomised, double-blind, placebo-controlled trial of hospitalised subjects with severe COVID-19 (pulmonary infiltrates and oxygen saturation ≤94% on room air) conducted at four tertiary care centres in India. 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. The secondary outcomes were 28-day mortality, time to clinical recovery, time to reverse transcription PCR negativity, adverse events, and others.Results 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.Conclusions 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.In this exploratory, multicentre, randomised, double-blind, placebo-controlled trial of 42 patients with severe #COVID19, a significantly better distribution of clinical status on days 14 and 21 was found for those randomised to the Mycobacterium w arm https://bit.ly/3q0sjOZ ER -