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].

Approach to post COVID-19 persistent cough: A narrative review.

A large proportion of patients who completely recovered from acute coronavirus disease 2019 (COVID-19) infection later continued to experience symptoms even after recovery, irrespective of the severity of the disease. Various terms with varying duration were used for those who had persistent symptoms, of which cough was the most common. We systematically searched the published literature concerning post-COVID-19 cough, its prevalence, and the potential ways to reduce it in clinical practice. The aim of this review was to provide an overview of existing literature concerning post-COVID-19 cough. Literature shows that augmented cough reflex sensitivity is responsible for persistent cough after acute viral upper respiratory infection (URI). Overall, the heightened cough reflex associated with SARSCoV2 induces neurotropism, neuroinflammation, and neuroimmunomodulation via the vagal sensory nerves. Therapies for post-COVID-19 cough aim at the suppression of cough reflex. For a patient who does not respond to early symptomatic treatment, Inhaled corticosteroids can be given a trial to suppress airway inflammation. More trials of novel cough therapies in patients with post-COVID-19 cough using various outcome measures need to be studied in future research. Several agents are currently available for symptomatic relief. However, non-response or refractory cough continues to preclude adequate symptom relief.

A rare case report of tracheobronchial aspergillosis with endobronchial aspergilloma in a patient clinically recovered from COVID-19.

The novel coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 has led to an increased incidence of fungal infections. However, pulmonary infections are rare. COVID-associated pulmonary aspergillosis has been reported; however, there is no prior report of tracheobronchial aspergillosis with endobronchial aspergilloma as per the authors' literature search. We report such a case of a 65-year-old male with radiology and biopsy-proven endobronchial aspergilloma upon a background of tracheobronchial and pulmonary aspergillosis after having recovered clinically from severe COVID-19 disease.

COVID-19 associated pulmonary mucormycosis: A systematic review of published cases with review of literature.

Background: There is sharp rise in cases of Coronavirus disease 2019 (COVID-19)-associated mucormycosis worldwide and specially during second wave of COVID-19 pandemic. This systemic review was conducted to characterize pulmonary mucormycosis associated with COVID-19 infection. Materials and Methods: A systematic literature search was conducted in the electronic database of PubMed and Google Scholar from 1st January 2020 to June 5, 2021 using keywords. Details of all the cases that reported pulmonary mucormycosis in people with COVID-19 so far, were retrieved and analyzed. Result: Total 9 articles of pulmonary mucormycosis with COVID-19 infection were reported in the database of PubMed and Google Scholar. Only one case till date was reported from India, others are from USA (n-3), Italy (n-2), France (n-1), UK (n-1), and Arizona (n-1). Pooled data from this study showed mucormycosis was predominantly seen in males (8 male, 1 female). The most common comorbidities associated were diabetes (n-3), hematological malignancy, (n-2) and end-stage renal disease (n-2), while 2 cases did not show any associated comorbidity. All the cases were having severe COVID-19 infection and 7 out of 9 patients were in ICU and on mechanical ventilation at the time of diagnosis. None of the cases associated with rhino-orbital-cerebral mucormycosis (ROCM) except 1 patient with sinus involvement. Mortality was found in 7 out of 9 patients. Conclusion: There is a need to keep a high index of suspicion in patients with severe COVID-19 infections, diabetic, and received treatment in ICU with ventilator support for early diagnosis and treatment. Although Mucor is less common than Aspergillus infection, it is associated with higher mortality.

Clinical Profile and Outcome of Haemodialysis in Patients With COVID-19 - A Single Centre Experience.

Introduction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 disease is the third coronavirus to have emerged in the last 20 years. The COVID-19 infection causes more severe illness in patients with comorbid diseases, especially in patients with diabetes, hypertension and kidney failure. Methods This is a retrospective study using electronic records and laboratory data of adult patients hospitalised at All India Institute of Medical Sciences (AIIMS), Patna between May 1st, 2020 and March 31st, 2021, who were diagnosed with COVID-19 and needed haemodialysis. The demographic characteristics, co-morbidities, symptoms, clinical course, laboratory parameters, and treatments were recorded. The aim of this study is to evaluate the clinical profile and outcome of patients on hemodialysis with COVID-19 infection. Results The study included 261 COVID-19 patients who needed haemodialysis. The most common symptoms on admission were fever (72.8%), cough (64.3%) and dyspnoea (46.6%). The mean age was 58.4 +/-15 years. A total of 195 patients (74.7%) were male. The most common co-morbid condition was hypertension (85.1%) followed by diabetes (71.9%). A total of 118 (45.2) patients had acute on chronic kidney disease (CKD), 40 (15.3) were on maintenance haemodialysis (MHD) and 103 (39.5) were having acute kidney injury (AKI). Eight patients were renal transplant recipients. At presentation, 183 (70.1%) patients were having mild to moderately severe infection and 78 (29.9%) patients were having severe disease. A total of 213 patients required ICU admissions, 186 (75.3%) of whom required invasive ventilation. Overall mortality was 66% (172/261) and the rest were discharged. Conclusion The study suggests that COVID-19 disease has a significantly more severe course and poorer outcome in patients requiring haemodialysis.

Study to identify predictor of hypoxia in COVID-19 infection: A single-center, retrospective study.

BACKGROUND: Given the limited availability of critical care resources in our country, it is important to identify reliable predictors of hypoxia in patients with COVID-19 infection. We thus sought to compare differential predictive values of demographic, clinical, and laboratory measures and identify predictor for hypoxia in COVID-19 infection. MATERIALS AND METHODS: This is single-center retrospective analysis of patient admitted at AIIMS Patna between 15th June and 15th Aug. All the patients who had oxygen saturation less than 94% grouped under hypoxic group while ≥94% in non-hypoxic group at room air. Statistical analysis: Logistic regression model used to determine the predictor of hypoxia in COVID-19 infection. RESULTS: Total 73 were used for analysis. Study patients had a mean age of 55.05 ± 12.7 year, of whom 78.08% were male (57/73). 39 (53.42%) patients were found hypoxic at time of admission while 34 (46.56%) were non-hypoxic. Presence of dyspnoea significantly found more frequently in hypoxic patients (P = 0.0003). Patients with O2 saturation of less than 94% have more likely to have diabetes (P = 0.002) and hypertension (P = 0.02). Analysis of laboratory variables showed that leucocytosis (P = 0.007) and neutrophilia (P = 0.01) were significantly higher in hypoxic group compare to non-hypoxic group. Univariate regression model showed patient with any one comorbidities, diabetes, or hypertension was found as strong risk factor for hypoxia after COVID-19 infection (P < 0.05). CONCLUSION: This is the first study to identify predictor of hypoxia in COVID-19 infection. Patient with any one comorbidities, diabetes, or hypertension was found strong risk factor for hypoxia after COVID-19 infection. Among lab variable, leucocytosis, neutrophilia, lymphocytopenia, and CRP (>27.5 mg/L) were found as predictor of hypoxia in COVID infection.

Post-COVID-19 pulmonary fibrosis: A case series and review of literature.

The most common lung problem faced by a post-COVID patient is lung fibrosis. Clinical recovery is generally complete in mild-to-moderately severe COVID-19 cases but a small proportion of patients with severe disease may go on to develop lung fibrosis. Patient groups at the highest risk to develop lung fibrosis are the elderly, especially those requiring ICU stay and mechanical ventilation. No definitive therapy for managing this pulmonary fibrosis exists as of date, even though various options are being explored. This case series highlights three cases of post-COVID lung fibrosis and reviews the existing literature.

Clinical Characteristics and Treatment Outcomes of 293 COVID-19 Patients Admitted to the Intensive Care Unit of a Tertiary Care Hospital of Eastern India.

OBJECTIVES OF THE STUDY: The objectives of the study were to assess the mortality among critically ill coronavirus disease (COVID) patients and to look at the factors which could have a bearing on mortality of these patients presenting to our designated tertiary COVID care institute. METHOD: This was a retrospective observational study involving all adult patients admitted to our intensive care unit (ICU) with coronavirus disease-2019 (COVID-19) infection between June 30, 2020, and August 31, 2020. We compared patient-related factors and laboratory test results among all survivors vs nonsurvivors in our ICU with an aim to predict the factors which could predict increased risks of mortality among sick patients admitted to our ICU. RESULTS AND CONCLUSION: The overall ICU mortality in our ICU during the study period was 76.69% and less than 5% of the patients requiring mechanical ventilation within 1 day of admission, survived. More than half of the deaths (54.66%) occurred within 5 days of ICU admission. The best predictors for mortality based upon the Cox proportional hazard ratio are increasing age, neutrophilia, increased D-dimer, prolonged stay in ICU for 1-2 weeks, and those requiring mechanical ventilation. Patients with one or more comorbidities were noted to have 16% of higher risk of death than those without any comorbidity. HOW TO CITE THIS ARTICLE: Rai DK, Sahay N, Lohani P. Clinical Characteristics and Treatment Outcomes of 293 COVID-19 Patients Admitted to the Intensive Care Unit of a Tertiary Care Hospital of Eastern India. Indian J Crit Care Med 2021;25(12):1395-1401.

Comparison of clinical and polysomnographic parameters between obese and nonobese obstructive sleep apnea.

INTRODUCTION: Obstructive sleep apnea (OSA) is one of the most common sleep-disordered breathing characterized by repeated cessation or reduction in airflow during sleep. OSA occurs in both obese and nonobese individual. This study was designed to compare the clinical and polysomnographic data between obese and nonobese patients with OSA. MATERIALS AND METHODS: This was a retrospective study that included all the patients diagnosed as between November 2013 and December 2014. The patients were classified into nonobese (n = 23) and obese (n = 72) groups if their body mass index (BMI) was <27.5 and ≥27.5, respectively. Data were analyzed using Statistical Package for the Social Sciences (SPSS) software program, version 20.0 (SPSS, Chicago, Illinois). A value of P < 0.05 was considered statistically significant. RESULTS: There were 95 patients of OSA, of which 23 (44.4%) were nonobese and 72 (75.78%) were obese with a mean BMI of 24.37 ± 3.09 and 34.27 ± 8.34 kg/m2, respectively. Characteristics, such as male predominance, higher BMI, neck circumference, and loud snoring, were significantly higher in obese group (P < 0.05) as compared to nonobese. Mild OSA (AHI 5-15) was significantly higher in nonobese patients (39.13% vs. 5.55%, P < 0.00001), whereas severe OSA (AHI >30) was higher in obese patients as compared with nonobese (66.66% vs. 30.43%, P = 0.002). When comparing comorbidities, the hypertension was significantly higher in the obese (47.22% vs. 13.04%, P = 0.003) than the nonobese patients. The incidence of diabetes (37.50% vs. 17.39%) and hypothyroidism (16.66% vs. 4.34%) was also higher in obese group as compared with nonobese. No significant difference was found for mean age, racial origin (Asian/African), and ESS score between obese and nonobese patients. CONCLUSION: Obstructive sleep apnoea is not restricted to only obese individual; rather it also occurs in nonobese. The severity of OSA in nonobese has generally less as compared with obese and its early identification required high index of suspicion.

Radiological difference between new sputum-positive and sputum-negative pulmonary tuberculosis.

INTRODUCTION: The current guidelines for the diagnosis of pulmonary tuberculosis (PTB) are based primarily on the demonstration of acid-fast bacilli (AFB) on sputum microscopy and chest radiograph. Knowing various radiological manifestations and their association with sputum microscopy findings can allow for early diagnosis and early initiation of treatment. AIMS: This study was performed to compare the chest radiograph features seen in sputum-positive and sputum-negative tuberculosis patients, respectively. MATERIALS AND METHODS: It was a prospective observational study, which included 147 consecutive patients newly diagnosed and treated as PTB between Jan 2018 and July 2018. Chest X-ray was reviewed by 2 independent radiologists and the findings were compared between sputum-positive and sputum-negative PTB cases. The obtained data were analyzed by statistics using SPSS version 15 for Windows (SPSS Inc., Chicago, IL) and χ2 test and Student t test were used for statistical analysis. P values < 0.05 were considered statistically significant. RESULTS: Out of a total of 147 patients, 38 (25 males and 13 females, mean age 35.23 ± 18.40) were sputum positive and 109 (77 males and 32 females, mean age 36.07 ± 18.15) were sputum negative. The frequency of patchy consolidation (78.94% vs 49.54%) and cavitation (36.84% vs 15.59%) was significantly higher in sputum-positive PTB (P < 0.05). Radiological lesions like nodular shadow (10.09% vs 2.63%), cystic lesion (13.76% vs 5.26%), fibrosis (12.84% vs 7.89%), miliary shadows (2.75% vs 2.63%), and pleural effusion (1.83% vs 0%) were seen more commonly with sputum-negative PTB but the difference was not statistically significant for any of these features. Sputum-positive PTB tends to occur more commonly on the left side (47.36%) compared with sputum-negative PTB (27.52%) (P < 0.05). 34.21% and 35.77% of the chest X-ray lesions were bilateral in sputum-positive and sputum-negative PTB, respectively. CONCLUSION: Patchy infiltration and cavitation on chest X-ray are seen more frequently in sputum-positive cases of PTB compared with sputum-negative cases.

Anabolic androgenic steroids in delayed diagnosis of tuberculosis.

This is the first case report depicting masking of symptoms of intestinal tuberculosis by anabolic androgenic steroids (AAS) causing delay in diagnosis which lead to a major surgery. Negative tuberculosis skin test (TST) probably due to immunomodulating effects of AAS also contributed to the delay. Patient also had early dependence on AAS and rapid growth of scrotal sebaceous cysts, findings of which have not yet been reported.