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 SP - 00059-2021 AU - Inderpaul Singh Sehgal AU - Randeep Guleria AU - Sarman Singh AU - Mohammad Sabah Siddiqui AU - Ritesh Agarwal AU - Inderpaul Singh Sehgal AU - Randeep Guleria AU - Sarman Singh AU - Mohammad Sabah Siddiqui AU - Anant Mohan AU - Atul Jindal AU - Ashish Bhalla AU - Kamal Kajal AU - Pankaj Malhotra AU - Goverdhan Dutt Puri AU - Sagar Khadanga AU - Rajnish Joshi AU - Saurabh Saigal AU - Nitin M. Nagarkar AU - Vikas Suri AU - Sushma Bhatnagar AU - Pawan Tiwari AU - Mini P. Singh AU - Laxmi Narayana Yaddanapudi AU - Sourab Mittal AU - Ritesh Agarwal A2 - , Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/02/25/23120541.00059-2021.abstract N2 - Purpose We investigate whether Mycobacterium w (Mw), an immunomodulator, would improve clinical outcomes in coronavirus infectious disease 19 (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 centers 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 score on days 7 and 14 compared to the baseline. The secondary outcomes were 28-day mortality, time to clinical recovery, time to RT-PCR negativity, adverse events, and othersResults 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Sehgal has nothing to disclose.Conflict of interest: Dr. Guleria has nothing to disclose.Conflict of interest: Dr. Singh has nothing to disclose.Conflict of interest: Dr. Siddiqui has nothing to disclose.Conflict of interest: Dr. Agarwal has nothing to disclose. ER -