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A randomised trial of Mycobacterium w in critically ill patients with COVID-19: ARMY-1.
Sehgal, Inderpaul Singh; Guleria, Randeep; Singh, Sarman; Siddiqui, Mohammad Sabah; Agarwal, Ritesh.
  • Sehgal IS; Dept of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
  • Guleria R; All India Institute of Medical Sciences, New Delhi, India.
  • Singh S; All India Institute of Medical Sciences, Bhopal, India.
  • Siddiqui MS; Dept of Medicine, All India Institute of Medical Sciences, Raipur, India.
  • Agarwal R; Dept of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
ERJ Open Res ; 7(2)2021 Apr.
Article in English | MEDLINE | ID: covidwho-1242237
ABSTRACT

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 11 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.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2021 Document Type: Article Affiliation country: 23120541.00059-2021

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2021 Document Type: Article Affiliation country: 23120541.00059-2021