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

ABSTRACT: We investigated whether Mycobacterium w (Mw), an immunomodulator, would improve clinical outcomes in coronavirus disease 2019 (COVID-19). 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

SUBMITTER: Sehgal IS 

PROVIDER: S-EPMC7942222 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature