Lung India

CASE LETTER
Year
: 2020  |  Volume : 37  |  Issue : 3  |  Page : 279--281

Safety of an immunomodulator Mycobacterium w in COVID-19


Inderpaul Singh Sehgal1, Ashish Bhalla2, Goverdhan Dutt Puri3, Laxmi Narayana Yaddanapudi3, Mini Singh4, Pankaj Malhotra2, Sahajal Dhooria1, Vikas Suri2, Ritesh Agarwal1,  
1 Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
2 Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
3 Department of Anesthesia and Critical Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India
4 Department of Virology, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Correspondence Address:
Ritesh Agarwal
Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh
India




How to cite this article:
Sehgal IS, Bhalla A, Puri GD, Yaddanapudi LN, Singh M, Malhotra P, Dhooria S, Suri V, Agarwal R. Safety of an immunomodulator Mycobacterium w in COVID-19.Lung India 2020;37:279-281


How to cite this URL:
Sehgal IS, Bhalla A, Puri GD, Yaddanapudi LN, Singh M, Malhotra P, Dhooria S, Suri V, Agarwal R. Safety of an immunomodulator Mycobacterium w in COVID-19. Lung India [serial online] 2020 [cited 2020 Jul 4 ];37:279-281
Available from: http://www.lungindia.com/text.asp?2020/37/3/279/283739


Full Text



Sir,

Coronavirus disease 2019 (COVID-19) pandemic is associated with a high mortality, especially in those with severe pneumonia. Patients with COVID requiring intensive care unit (ICU) admission have higher cytokine levels compared to those who do not need ICU care.[1] Even among patients admitted to ICU, those discharged from hospital had lower cytokine levels compared to those who died.[2] An immunomodulator may thus be of potential benefit in managing these critically ill COVID patients. The Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R) and the World Health Organization have identified adjuvant therapy as one of the key areas of research to save lives of patients infected with COVID-19.[3] A heat-killed Mycobacterium w (Mw), originally developed as an immunomodulator for leprosy, which acts through the toll-like receptors (TLRs) pathway and enhances the host-T cell responses.[4] We have previously shown the benefit of Mw in patients with severe sepsis.[5] Herein, we describe the safety of Mw in four cases of severe COVID treated with this immunomodulator [Table 1].{Table 1}

All the four patients presented with a history of fever, myalgia, and dyspnea and had a history of contact with a patient of COVID-19. At presentation, patients had tachypnea [Table 1] and were hypoxemic at room air. Complete blood count showed neutrophil predominant leukocytosis and lymphocytopenia [Table 1]. The serum D-dimer levels were elevated in all patients at presentation and were >500 ng/mL in one patient. C-reactive protein (CRP) levels were also elevated in all patients, suggesting a hyperinflammatory state. Creatine kinase–myocardial band was elevated in all patients; however, transthoracic echocardiography did not reveal any abnormality. As per our institutional protocol, all patients received standard medical care comprising oral paracetamol (for fever), oral proton-pump inhibitor for stress ulcer prophylaxis (pantoprazole 40 mg/day), and low-molecular-weight heparin for deep venous thrombosis prophylaxis (enoxaparin 1 mg/kg, once daily). Therapeutic anticoagulation (enoxaparin 1 mg/kg, twice daily) was given in patients who had D-dimer levels >500 ng/mL. We used antibiotics (azithromycin or ceftriaxone) if patients had a total leukocyte count of >11,000 cell/μL, procalcitonin >0.5 ng/mL, or if they had hypotension (mean arterial blood pressure <65 mmHg). We did not use hydroxychloroquine in any of these patients. We also used intradermal Mw (0.3 mL/day [0.1 mL contains 0.5 × 10(9) heat-killed Mw] for 3 consecutive days, Immuvac, Cadila Pharmaceuticals, Ahmedabad, India) in addition to standard medical care.

The treatment protocol resulted in clinical and radiological improvement in all the cases [Figure 1]. The CRP levels improved gradually [Figure 2], and all the patients could be successfully managed without the need for mechanical ventilation. Importantly, Mw did not cause any adverse events, similar to our previous experience in patients with severe sepsis.[5]{Figure 1}{Figure 2}

Based on our preliminary experience, we believe that adjunctive Mw is safe in patients with severe COVID-19 infection. However, the efficacy needs to be evaluated in a future randomized controlled trial (clinicaltrials.gov: NCT04347174).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
2Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med 2020; doi:10.1007/s00134-020-05991-x.
3COVID 19 Public Health Emergency of International Concern Global Research and Innovation Forum: Towards a Research Roadmap; 2020. Available from: https://www.who.int/blueprint/priority-diseases/key-action/Global_Research_Forum_FINAL_VERSION_for_web_14_feb_2020.pdf?ua=1. [Last accessed on 2020 Mar 23].
4Desai NM, Khamar BM. Immunotherapy for tuberculous pericarditis. N Engl J Med 2014;371:2533-4.
5Sehgal IS, Agarwal R, Aggarwal AN, Jindal SK. A randomized trial of Mycobacterium w in severe sepsis. J Crit Care 2015;30:85-9.