Inderpaul S Sehgal, Ritesh Agarwal, Atul Jindal, Md Sabah Siddiqui, Anant Mohan, Arnab Pal, Randeep Guleria, Ashish Bhalla, Kamal Kajal, Pankaj Malhotra, Goverdhan Dutt Puri, Sagar Khadanga, Rajnish Joshi, Sarman Singh, Saurabh Saigal, Nitin M Nagarkar, Vikas Suri, Sushma Bhatnagar, Pawan Tiwari, Mini P Singh, Laxmi Narayana Yaddanapudi, Saurabh Mittal, Anshika Chauhan, Gaurab Banerjee, Deependra K Rai, Bikram K Gupta
{"title":"用 COVID-19 （ARMY-2）对重症患者进行分枝杆菌 w 的多中心、双盲、安慰剂对照随机试验。","authors":"Inderpaul S Sehgal, Ritesh Agarwal, Atul Jindal, Md Sabah Siddiqui, Anant Mohan, Arnab Pal, Randeep Guleria, Ashish Bhalla, Kamal Kajal, Pankaj Malhotra, Goverdhan Dutt Puri, Sagar Khadanga, Rajnish Joshi, Sarman Singh, Saurabh Saigal, Nitin M Nagarkar, Vikas Suri, Sushma Bhatnagar, Pawan Tiwari, Mini P Singh, Laxmi Narayana Yaddanapudi, Saurabh Mittal, Anshika Chauhan, Gaurab Banerjee, Deependra K Rai, Bikram K Gupta","doi":"10.4103/lungindia.lungindia_426_23","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19.</p><p><strong>Materials and methods: </strong>In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome 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 key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others.</p><p><strong>Results: </strong>We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw.</p><p><strong>Conclusion: </strong>Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].</p>","PeriodicalId":47462,"journal":{"name":"Lung India","volume":"41 2","pages":"84-92"},"PeriodicalIF":1.3000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10959309/pdf/","citationCount":"0","resultStr":"{\"title\":\"A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2).\",\"authors\":\"Inderpaul S Sehgal, Ritesh Agarwal, Atul Jindal, Md Sabah Siddiqui, Anant Mohan, Arnab Pal, Randeep Guleria, Ashish Bhalla, Kamal Kajal, Pankaj Malhotra, Goverdhan Dutt Puri, Sagar Khadanga, Rajnish Joshi, Sarman Singh, Saurabh Saigal, Nitin M Nagarkar, Vikas Suri, Sushma Bhatnagar, Pawan Tiwari, Mini P Singh, Laxmi Narayana Yaddanapudi, Saurabh Mittal, Anshika Chauhan, Gaurab Banerjee, Deependra K Rai, Bikram K Gupta\",\"doi\":\"10.4103/lungindia.lungindia_426_23\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19.</p><p><strong>Materials and methods: </strong>In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome 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 key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others.</p><p><strong>Results: </strong>We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw.</p><p><strong>Conclusion: </strong>Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].</p>\",\"PeriodicalId\":47462,\"journal\":{\"name\":\"Lung India\",\"volume\":\"41 2\",\"pages\":\"84-92\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10959309/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lung India\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/lungindia.lungindia_426_23\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung India","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/lungindia.lungindia_426_23","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/27 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2).
Background: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19.
Materials and methods: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome 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 key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others.
Results: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw.
Conclusion: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].
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