Effect of volume of instillate on the diagnostic utility of bronchoalveolar lavage galactomannan in patients with suspected chronic pulmonary aspergillosis-A pilot study.

BACKGROUND: Bronchoalveolar lavage (BAL) galactomannan (GM) is commonly used to diagnose Aspergillus-related lung diseases. However, unlike serum GM, which is measured in undiluted blood, BAL-GM is estimated using variable aliquots and cumulative volume of instillates during bronchoscopy. OBJECTIVE: Since different studies have reported varying diagnostic accuracy and cut-offs for BAL-GM in CPA, we hypothesized that the total volume of instillate and 'order/label' of aliquots significantly affects the BAL-GM values, which was evaluated as part of this study. PATIENTS & METHODS: We obtained 250 BAL samples from 50 patients (five from each) with suspected chronic pulmonary aspergillosis. BAL fluid was collected after instilling sequential volumes of 40 mL of normal saline each for the first four labels and a fifth label was prepared by mixing 1 mL from each of the previous labels. The GM level of each label was measured by PLATELIA™ ASPERGILLUS Ag enzyme immunoassay. This study measured the discordance, level of agreement, diagnostic characteristics (sensitivity, specificity and AUROC) and best cut-offs for BAL-GM in the different aliquots of lavage fluid. RESULTS: The study population, classified into CPA (28%) and non-CPA (72%) groups, based on ERS/ESCMID criteria (excluding BAL-GM) were not different with respect to clinico-radiological characteristics. The discordance of BAL-GM positivity (using a cut-off of >1) between the serial labels for the same patient ranged between 10% and 22%, while the discordance between classification using BAL-GM positivity (using a cut-off of ≥1) and clinic-radio-microbiological classification ranged between 18% and 30%. The level of agreement for serial labels was at best fair (<0.6 for all except one 'label'). The AUROC for the serial samples ranged between 0.595 and 0.702, with the '40 mL and the 'mix' samples performing the best. The best BAL-GM cut-off also showed significant variation between serial labels of varying dilutions (Range:1.01 - 4.26). INTERPRETATION: This study highlights the variation in BAL-GM measured and the 'positivity' between different 'labels' of aliquots of BAL, with the first aliquot and the mixed sample showing the best performances for diagnosis of CPA. Future studies should attempt to 'standardise' the instilled volume for BAL-GM estimation to standardise the diagnostic yield.

Malarial Antibodies and Endemicity: Does It Affect SARS-CoV-2 Severity and Outcomes?

Background India has a disproportionately lower rate of coronavirus disease 2019 (COVID-19) severe disease and lower death rates with respect to other parts of the world. It has been proposed that malaria-endemic countries such as India are relatively protected against severe COVID-19 disease and deaths. Methods This was a cross-sectional, analytical, observational study conducted from August 2020 to July 2021 at a tertiary care COVID-19-designated center in New Delhi, India. It aimed to study the association between antimalarial antibody levels and COVID-19 disease severity and outcomes. Results One hundred forty-six patients were included in the final analysis. The mean (standard deviation {SD}) age of the study population was 44.6 (17.2) years, and there were 85 (58.2%) males. Sixty-five patients had mild disease, 14 patients had moderate disease, and 67 patients had severe disease at the time of enrolment in the study. Forty-six patients expired during the hospital stay. For the antimalarial antibody, there was a statistically significant difference between mild and moderate (p=0.018), mild and severe (p=0.016), and mild and combined moderate and severe diseases (p=0.013). However, there was no difference between the patients who survived and those who did not. Conclusion Antimalarial antibody levels may not be associated with the outcomes of COVID-19 during hospital stay. However, this study has provided some insights into the relationship between the severity and outcomes of COVID-19 and the levels of antimalarial antibodies.

The Utility of Galactomannan and Polymerase Chain Reaction Assays in Bronchoalveolar Lavage for Diagnosis of Chronic Pulmonary Aspergillosis.

The diagnosis of chronic pulmonary aspergillosis (CPA) is established by combined clinic-radio-microbiological criteria. Out of the different microbiological criteria, a positive serology for Aspergillus-specific IgG levels is the cornerstone of diagnosis. Alternatively, other microbiological evidence are sometimes sought viz., positive Aspergillus antigen (broncho-alveolar lavage fluid, i.e., BALF galactomannan ≥ 1.0), histopathological demonstration of the fungi following lung biopsy or resection, demonstration of hyaline septate hyphae in direct microscopy resembling Aspergillus spp. or its growth on a respiratory specimen. However, the exact roles of BALF- GM and the newer BALF-PCR have not been confirmed by studies till date. This study enrolled 210 patients with suspected CPA. Of the participants, 88 patients met the criteria for CPA, whereas 122 patients had an alternative diagnosis. The sensitivity-specificity of AsperGenius® PCR and "in-house" PCR were 52.27(36.69-67.54) %-33.78 (23.19-45.72) % and 36.36 (22.41-52.23) %-39.19 (28.04-51.23) % respectively. The sensitivity/specificity of BALF (> 1.0) and serum galactomannan (> 1.0) were 46.55% (33.34-60.13)/64.08% (54.03-73.3) and 29.82% (22.05-37.6)/86.84% (81.1-92.59) respectively. The optimal cut-off values for BALF-Galactomannan and serum galactomannan in diagnosing CPA were found to be 0.69 (sensitivity: 64%; specificity: 53%) and 0.458 (sensitivity: 67%; specificity: 64%) respectively. This results of this study suggests that Aspergillus PCR from BAL may not be a good "rule-in" test for diagnosing CPA. While the performances of GM in BAL and serum may be better than PCR, it should be best used in conjunction with other clinical, radiological, and other microbiological characteristics.

Mortality in Two Waves of COVID-19: A Comparative Analysis of a Tertiary Care Hospital in India.

Background COVID-19 has spread as two distinct surges of cases in many countries. Several countries have reported differences in disease severity and mortality in the two waves. Objective Compare the in-hospital mortality in the two COVID-19 waves at a tertiary care hospital in India. Methods We conducted a retrospective data collection. Distinct periods of surges in cases and admissions were defined as the first wave spanning from March 2020 to December 2020 and the second wave from April 2021 to June 21, 2021. The primary outcome of this study was to compare mortality rates in terms of total hospital mortality rate (TMR) and case fatality rate (CFR). Results Mortality rates of wave 2 were approximately 10 times that of wave 1 (TMR of 20.3% in wave 2 versus 2.4% in wave 1 and CFR of 1.5% versus 17.7% in wave 1 and 2, respectively). Mortalities in wave 2 had a larger proportion of severe disease at presentation, faster progression of symptoms to death, and more patients without any chronic comorbid condition dying due to the direct effect of COVID-19 acute respiratory distress syndrome (ARDS). Conclusion Our data matches the worldwide reported pooled hospital mortality figures and shows the comparative difference in disease severity between the two waves.

Analysis of Hematological Indices in Patients of Systemic Lupus Erythematous and Its Correlation with SLEDAI-2K.

Background: Systemic lupus erythematosus (SLE) is an autoimmune disease which is characterized by chronic multisystem inflammation and end-organ damage. In recent times there has been a need for new hematological markers to assess disease activity in SLE patients specifically, which can be easily available like eosinophil, basophil, neutrophil, monocytes, and platelet to lymphocyte ratios (ELR, BLR, NLR, MLR, and PLR, respectively). Materials and methods: The present investigation determines the use of a different peripheral hematological marker to assess SLE activity in 106 patients attended for medical care at Sawai Mansingh (SMS) Medical College and attached hospital, Jaipur. SLE disease activity index 2000 (SLEDAI-2K) was used to assess the disease activity in all patients. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were assessed in each subject. The ratio of various hematological indices, like NLR, BLR, ELR, MLR, PLR, etc., analyzed and correlated with CRP, ESR, and SLEDAI-2K. Results: The present study revealed that the SLEDAI-2K score showed a significant positive correlation with ELR and MLR (p < 0.005). CRP showed a significant positive correlation with PLR (p < 0.005). ESR showed a significant positive correlation with ELR, MLR, PLR, and NLR (p < 0.005). Conclusion: The final results demonstrate that in SLE patients, the ratio of hematological indices like ELR, MLR, and PLR can be employed as disease activity markers. How to cite this article: Meena VP, Meena PD, Chejara RS, et al. Analysis of Hematological Indices in Patients of Systemic Lupus Erythematous and Its Correlation with SLEDAI-2K. J Assoc Physicians India 2023;71(11):40-42.

Clinical profile of ChAdOx1 nCoV-19- and BBV152-vaccinated individuals among hospitalized COVID-19 patients: a pair-matched study.

Background: COVID-19 infections among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-vaccinated individuals are of clinical concern, especially in those requiring hospitalization. Such real-world data on ChAdOx1 nCoV-19- and BBV152-vaccinated individuals are scarce. Hence, there is an urgent need to understand their clinical profile and outcomes. Methods: A 1:1 pair-matched study was performed among vaccinated and unvaccinated COVID-19 patients admitted between March 2021 and June 2021 at a tertiary care centre in New Delhi, India. The vaccinated group (received at least one dose of ChAdOx1 nCoV-19 or BBV152) was prospectively followed till discharge or death and matched [for age (±10 years), sex, baseline disease severity and comorbidities] with a retrospective group of unvaccinated patients admitted during the study period. Paired analysis was done to look for clinical outcomes between the two groups. Results: The study included a total of 210 patients, with 105 in each of the vaccinated and unvaccinated groups. In the vaccinated group, 47 (44.8%) and 58 (55.2%) patients had received ChAdOx1 nCoV-19 and BBV152, respectively. However, 73 patients had received one dose and 32 had received two doses of the vaccine. Disease severity was mild in 36.2%, moderate in 31.4% and severe in 32.4%. Two mortalities were reported out of 19 fully vaccinated individuals. All-cause mortality in the vaccinated group was 8.6% (9/105), which was significantly lower than the matched unvaccinated group mortality of 21.9% (23/105), p = 0.007. Vaccination increased the chances of survival (OR = 3.8, 95% CI: 1.42-10.18) compared to the unvaccinated group. Conclusion: In the second wave of the pandemic predominated by delta variant of SARS CoV-2, vaccination reduced all-cause mortality among hospitalized patients, although the results are only preliminary.

Development and Validation of a Questionnaire to Assess the Risk Factors, Facilitators, and Barriers to Postpartum Weight Management.

Background: Postpartum period is associated with significant weight retention and weight gain. The aim of this study was to develop and validate a comprehensive questionnaire to assess the risk factors, facilitators, and barriers to postpartum weight management. Methodology: The development and validation were done in five major steps by applying a mixed-method study design. Items were generated through literature review, focus group discussions, and in-depth interviews, followed by the assessment of content validity, face validity, construct validity, and reliability. Result: The final questionnaire comprises 36 items which are split into five major domains assessing perceptions related to body weight, eating behaviour, physical activity, sleep pattern, and beliefs/myths associated with postpartum period. The questionnaire has a satisfactory construct validity through factor analysis (65.12) and good internal consistency and reliability with a Cronbach's alpha of 0.79. Conclusion: This is a comprehensive tool to assess the risk factors, facilitators, and barriers to postpartum weight management and will aid in developing women centric strategies to curb the problem. Supplementary Information: The online version contains supplementary material available at 10.1007/s13224-022-01631-0.

Efficacy of LD Bio Aspergillus ICT Lateral Flow Assay for Serodiagnosis of Chronic Pulmonary Aspergillosis.

Background: The diagnosis of CPA relies on the detection of the IgG Aspergillus antibody, which is not freely available, especially in resource-poor settings. Point-of-care tests like LDBio Aspergillus ICT lateral flow assay, evaluated in only a few studies, have shown promising results for the diagnosis of CPA. However, no study has compared the diagnostic performances of LDBio LFA in setting of tuberculosis endemic countries and have compared it with that of IgG Aspergillus. Objectives: This study aimed to evaluate the diagnostic performances of LDBio LFA in CPA and compare it with existing the diagnostic algorithm utilising ImmunoCAP IgG Aspergillus. Methods: Serial patients presenting with respiratory symptoms (cough, haemoptysis, fever, etc.) for >4 weeks were screened for eligibility. Relevant investigations, including direct microscopy and culture of respiratory secretions, IgG Aspergillus, chest imaging, etc., were done according to existing algorithm. Serums of all patients were tested by LDBio LFA and IgG Aspergillus (ImmunoCAP Asp IgG) and their diagnostic performances were compared. Results: A total of 174 patients were included in the study with ~66.7% patients having past history of tuberculosis. A diagnosis of CPA was made in 74 (42.5%) of patients. The estimated sensitivity and specificity of LDBio LFA was 67.6% (95% CI: 55.7−78%) and 81% (95% CI: 71.9−88.2%), respectively, which increased to 73.3% (95% CI: 60.3−83.9%) and 83.9% (95% CI: 71.7−92.4%), respectively, in patients with a past history of tuberculosis. The sensitivity and specificity of IgG Aspergillus was 82.4% (95% CI: 71.8−90.3%) and 82% (95% CI: 73.1−89%); 86.7% (95% CI: 75.4−94.1%) and 80.4% (95% CI: 67.6−89.8%), in the whole group and those with past history of tuberculosis, respectively. Conclusions: LDBio LFA is a point-of-care test with reasonable sensitivity and specificity. However, further tests may have to be done to rule-in or rule-out the diagnosis of CPA in the appropriate setting.

Silent Hypoxia in Coronavirus disease-2019: Is it more dangerous? -A retrospective cohort study.

Background: Hypoxia in patients with COVID-19 is one of the strongest predictors of mortality. Silent hypoxia is characterised by the presence of hypoxia without dyspnoea. Silent hypoxia has been shown to affect the outcome in previous studies. Methods: This was a retrospective study of a cohort of patients with SARS-CoV-2 infection who were hypoxic at presentation. Clinical, laboratory and treatment parameters in patients with silent hypoxia and dyspnoeic hypoxia were compared. Multivariate logistic regression models were fitted to identify the factors predicting mortality. Results: Among 2080 patients with COVID-19 admitted to our hospital, 811 patients were hypoxic with SpO2 <94% at the time of presentation. Among them, 174 (21.45%) did not have dyspnoea since the onset of COVID-19 symptoms. Further, 5.2% of patients were completely asymptomatic for COVID-19 and were found to be hypoxic only on pulse oximetry. The case fatality rate in patients with silent hypoxia was 45.4% as compared to 40.03% in dyspnoeic hypoxic patients (P = 0.202). The odds ratio of death was 1.1 (95% CI: 0.41-2.97) in the patients with silent hypoxia after adjusting for baseline characteristics, laboratory parameters, treatment and in-hospital complications, which did not reach statistical significance (P = 0.851). Conclusion: Silent hypoxia may be the only presenting feature of COVID-19. As the case fatality rate is comparable between silent and dyspnoeic hypoxia, it should be recognised early and treated as aggressively. Because home isolation is recommended in patients with COVID-19, it is essential to use pulse oximetry in the home setting to identify these patients.

Awareness, Beliefs and Perspectives Regarding Weight Retention and Weight Gain among Postpartum Women in India: A Thematic Analysis of Focus Group Discussions and In-Depth Interviews.

Background and Aims: The pregnancy weight is usually retained in the form of abdominal fat during the postpartum period. The willingness to lose weight is influenced by knowledge, attitude, beliefs and practices. This study aims to comprehend the awareness, beliefs and perspectives of postpartum women regarding their perceived factors, barriers and facilitators associated with post-pregnancy weight status. Methods: Overweight and obese postpartum women aged between 20 and 40 years and had delivered an infant in the last 2 years were recruited via convenience and purposive sampling techniques. The final sample comprised 27 participants with a mean age of 29.96 ± 4.50 years. Four focus group discussions and eight in-depth interviews carried out were audio-recorded and transcribed verbatim. Codes, sub-themes and themes were generated using Atlas.ti 9 software. Results: Major themes identified were perceived factors causing postpartum weight retention/weight gain including social and cultural beliefs related to diet and exercise specifically associated with this period, perceived motivators and deterrents of weight loss including eagerness to lose weight and perceived facilitators and barriers to weight loss including intrinsic and extrinsic factors such as time, energy, evidence-based knowledge about diet and physical activity, family support and obligation to family's advice. Conclusion: The unique challenges and barriers associated with postpartum weight loss efforts should be taken into consideration by healthcare professionals and public health policy-makers to design strategies specific to postpartum women. Supplementary Information: The online version contains supplementary material available at 10.1007/s13224-022-01644-9.

Risk factors for Coronavirus disease-associated mucormycosis.

BACKGROUND: The epidemiology of the Coronavirus-disease associated mucormycosis (CAM) syndemic is poorly elucidated. We aimed to identify risk factors that may explain the burden of cases and help develop preventive strategies. METHODS: We performed a case-control study comparing cases diagnosed with CAM and taking controls as recovered COVID 19 patients who did not develop mucormycosis. Information on comorbidities, glycemic control, and practices related to COVID-19 prevention and treatment was recorded. Multivariate regression analysis was used to identify independent predictors. RESULTS: A total of 352 patients (152 cases and 200 controls) diagnosed with COVID-19 during April-May 2021 were included. In the CAM group, symptoms of mucormycosis began a mean of 18.9 (SD 9.1) days after onset of COVID-19, and predominantly rhino-sinus and orbital involvement was present. All, but one, CAM cases had conventional risk factors of diabetes and steroid use. On multivariable regression, increased odds of CAM were associated with the presence of diabetes (adjusted OR 3.5, 95% CI 1.1-11), use of systemic steroids (aOR 7.7, 95% CI 2.4-24.7), prolonged use of cloth and surgical masks (vs. no mask, aOR 6.9, 95%CI 1.5-33.1), and repeated nasopharyngeal swab testing during the COVID-19 illness (aOR 1.6, 95% CI 1.2-2.2). Zinc therapy was found to be protective (aOR 0.05, 95%CI 0.01-0.19). Notably, the requirement of oxygen supplementation or hospitalization did not affect the risk of CAM. CONCLUSION: Judicious use of steroids and stringent glycemic control are vital to preventing mucormycosis. Use of clean masks, preference for N95 masks if available, and minimizing swab testing after the diagnosis of COVID-19 may further reduce the incidence of CAM.

Clinical features, demography, and predictors of outcomes of SARS-CoV-2 infection at a tertiary care hospital in India: A cohort study.

BACKGROUND: The "second wave" of the COVID-19 pandemic hit India from early April 2021 to June 2021. We describe the clinical features, treatment trends, and baseline laboratory parameters of a cohort of patients with SARS-CoV-2 infection and their association with the outcome. METHODS: This was a retrospective cohort study. Multivariate logistic regression models were fitted to identify clinical and biochemical predictors of developing hypoxia, deterioration during the hospital stay, and death. RESULTS: A total of 2080 patients were included. The case fatality rate was 19.5%. Among the survivors, the median duration of hospital stay was 8 (5-11) days. Out of 853 (42.3%%) of patients who had COVID-19 acute respiratory distress syndrome at presentation, 340 (39.9%) died. Patients aged >45 years had higher odds of death as compared to the 18-44 years age group. Vaccination reduced the odds of death by 40% (odds ratio [OR] [95% confidence interval [CI]]: 0.6 [0.4-0.9], P = 0.032). Patients with hyper inflammation at baseline as suggested by leukocytosis (OR [95% CI]: 2.1 [1.5-3.1], P < 0.001), raised d-dimer >500 mg/dL (OR [95% CI]: 3.2 [2.2-4.7], P < 0.001), and raised C-reactive peptide >0.5 mg/L (OR [95% CI]: 3.7 [2.2-13], P = 0.037) had higher odds of death. Patients who were admitted in the 2nd week had lower odds and those admitted in the 3rd week had higher odds of death. CONCLUSION: This study shows that vaccination status and early admission during the inflammatory phase can change the course of illness of these patients. Improving vaccination rates and early admission of patients with moderate and severe COVID-19 can improve the outcomes.

Utility of nasal application of lignocaine gel using cotton tip swab versus squirting with slip-tip syringe for transnasal fibreoptic bronchoscopy: a pilot randomised controlled trial.

BACKGROUND: During flexible fibreoptic bronchoscopy through the nasal route, anaesthesia of the nasal passage is achieved by lignocaine gel application by a slip-tip syringe or with the help of a cotton tip swab. No studies in existing literature have compared the two techniques in terms of efficacy. METHODS: 137 consecutive patients undergoing bronchoalveolar lavage (BAL) were recruited over a 2-year period. The patients underwent BAL after nasal anaesthesia-either by slip-tip syringe or by cotton tip swab smeared with 2% lignocaine gel. Patients were monitored for intraprocedural epistaxis, discomfort and improvement in operator visibility of nasal passage. RESULTS: 67 patients were randomised to cotton swab and 70 patients to the gel instillation group. There were no significant differences in terms of epistaxis, 29.9% in the cotton tip swab (95% CI 19.3% to 42.3%) versus 24.3% in the gel instillation group (95% CI 14.8% to 36%) or detection of nasal blocks, 7.5% in the cotton tip swab (95% CI 2.5% to 16.6%) versus 10% in the gel instillation group (95% CI 4.1% to 19.5%) in the two groups, although a significant difference was there in terms of visibility, 73.1% in the cotton tip swab (95% CI 60.9% to 83.2%) versus 42.9% in the gel instillation group (95% CI 31.1% to 55.3%). There was no difference in the mean pain score across the two groups either during the procedure or 1 hour after it. A short systematic review of existing literature on the topic has been provided for comparison. CONCLUSION: Application of 2% lignocaine gel by slip-tip syringe and cotton tip swab are equivalent in terms of observed and narrated pain experienced by patients, frequency of epistaxis and nasal blocks. Vision was better preserved in the cotton tip swab group.

The Effectiveness of SARS-CoV-2 Vaccination in Preventing Severe Illness and Death - Real-world Data from a Cohort of Patients Hospitalized with COVID-19.

Background: While long-term studies on the correlates of protection, vaccine effectiveness, and enhanced surveillance are awaited for SARS-CoV-2 vaccine, studies on breakthrough infections help understand the nature and course of this illness among vaccinated individuals and guide in public health preparedness. This study aims to compare the differences in the hospitalization outcomes SARS-CoV-2 infection of fully vaccinated individuals with with those of unvaccinated and partially vaccinated individuals. Materials and Methods: Single institution observational cohort study. This study compared the differences in clinical, biochemical parameters and the hospitalization outcomes of 53 fully vaccinated individuals with those of unvaccinated (1464) and partially vaccinated (231) individuals, among a cohort of 2,080 individuals hospitalized with SARS-CoV-2 infection. Descriptive statistics and propensity-score weighted multivariate logistic regression analysis adjusting for clinical and laboratory parameters were used to compare the differences and to identify factors associated with outcomes. Results: Completing the course of vaccination protected individuals from developing severe COVID-19 as evidenced by lower proportions of those with hypoxia, abnormal levels of inflammatory markers, requiring ventilatory support, and death compared to unvaccinated and partially vaccinated individuals. There were no differences in these outcomes among patients who received either vaccine type approved in India. Conclusions: Efforts should be made to improve the vaccination rates as a timely measure to prepare for the upcoming waves of this highly transmissible pandemic. Vaccination rates of the communities may also guide in the planning of the health needs and appropriate use of medical resources.

Covid-19 presenting as isolated severe thrombocytopenia in an HIV-lymphoma survivor.

Coronavirus disease has myriad manifestations and can present with predominantly extrapulmonary manifestations. We describe a 50-year-old man, a person living with HIV (PLHA), a non-Hodgkin lymphoma survivor, who presented with isolated severe thrombocytopenia. He was found to have immune-mediated thrombocytopenia, and showed excellent response to intravenous immunoglobulins.

Single-dose oral ivermectin in mild and moderate COVID-19 (RIVET-COV): A single-centre randomized, placebo-controlled trial.

INTRODUCTION: Ivermectin is an antiparasitic drug which has in-vitro efficacy in reducing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) viral load. Hence, Ivermectin is under investigation as a repurposed agent for treating COVID-19. METHODS: In this pilot, double blind, randomized controlled trial, hospitalized patients with mild-to-moderate COVID-19 were assigned to a single oral administration of an elixir formulation of Ivermectin at either 24 mg or 12 mg dose, or placebo in a 1:1:1 ratio. The co-primary outcomes were conversion of RT-PCR to negative result and the decline of viral load at day 5 of enrolment. Safety outcomes included total and serious adverse events. The primary outcomes were assessed in patients who had positive RT-PCR at enrolment (modified intention-to-treat population). Safety outcomes were assessed in all patients who received the intervention (intention-to-treat population). RESULTS: Among the 157 patients randomized, 125 were included in modified intention-to-treat analysis. 40 patients each were assigned to Ivermectin 24 mg and 12 mg, and 45 patients to placebo. The RT-PCR negativity at day 5 was higher in the two Ivermectin arms but failed to attain statistical significance (Ivermectin 24 mg, 47.5%; 12 mg arm, 35.0%; and placebo arm, 31.1%; p-value = 0.30). The decline of viral load at day 5 was similar in each arm. No serious adverse events occurred. CONCLUSIONS: In patients with mild and moderate COVID-19, a single oral administration of Ivermectin did not significantly increase either the negativity of RT-PCR or decline in viral load at day 5 of enrolment compared with placebo.

Fifty Shades of COVID-19 - Immune Thrombocytopenic Purpura in HIV-TB-COVID Co-Infection.

SARS CoV-2 infection is associated with various hematological manifestations, including leucopenia, thrombocytopenia, thrombocytopenia. Severe thrombocytopenia is, however, rare and is associated with severe COVID-19. ITP remains an important differential among other causes. We report a case of HIV-TB-COVID-19 co-infection, without any feature of severe COVID, presenting with severe thrombocytopenia which resolved on its own; cause was attributed to immune-mediated effect of SARS CoV-2 virus.

Head and Neck Surgery During COVID-19 Pandemic: Experience from a Tertiary Care in India.

Head and neck pathologies requiring surgical intervention are considered a high-risk subsite in the context of COVID-19 pandemic by virtue of its close proximity to the mucosa of the upper aerodigestive tract. Retrospective review of all head and neck surgical procedures is undertaken during the pandemic from 23rd April 2020 to 30th September 2020. One hundred procedures were performed on 98 patients. COVID-19 status determined by SARS-Cov-2 RT-PCR at baseline was negative for 81, positive in 8 and unknown in 11. The RT-PCR negative subgroup included 40 diagnostic procedures and 41 ablative and or reconstructive procedures for head and neck neoplasms. None of the patients or health-care workers converted to COVID-19-positive status during the duration of the hospital stay. There were no cases with 30-day mortality. Clavien-Dindo grading for postoperative complications was as follows: 1-4, 2-12, 3a-2, 3b-1. Eleven patients with unknown COVID-19 status at baseline underwent emergency tracheostomy in a COVID-19 designated operating room for upper airway obstruction secondary to head and neck cancer. Of the 8 procedures conducted on known cases of COVID-19, 6 were tracheostomies performed for COVID-19 ARDS. The rest were maxillectomy for acute invasive mucormycosis and incision and drainage for parotid abscess. A matched-pair analysis was performed with similarly staged historical cohort operated during January to December 2016 to compare peri-operative complication rates (Clavien-Dindo Score). Incidence of complication with higher Clavien Dindo Score (>/=3a) was found to be lower in those patients operated during the pandemic (p=0.007). By meticulous preoperative COVID-19 screening and isolation, head and neck surgical procedures can be continued to avoid delay in diagnosis and treatment without jeopardising the risk of transmission of COVID-19 to the patients or health-care workers.

Gargle lavage & saliva: Feasible & cheaper alternatives to nasal & throat swabs for diagnosis of COVID-19.

Background & objectives: In the present scenario, the most common sample for diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) is nasal and throat swab (NTS). Other sampling options such as gargle lavage have found limited application in clinical use mostly because of unavailability of an appropriate gargling liquid. This study was conducted to assess the stability of SARS-CoV-2 RNA in normal saline at 4°C that can serve as a gargling liquid as well as a transport medium. The study also looked at the agreement between NTS and gargle lavage/saliva for the detection of SARS-CoV-2. Methods: In 29 consecutive real-time RT-PCR (rRT-PCR) positive COVID-19 patients, paired NTS, gargle and saliva samples were taken. Samples were processed by rRT-PCR for the detection of SARS-CoV-2 RNA. To assess the SARS-CoV-2 RNA stability in normal saline, gargle lavage specimens were divided into two aliquots; one subset of the specimen was run within 4-6 h along with the routine samples (NTS and saliva) and the other subset was stored at 4°C and processed after 24-30 h. Agreement between cycle threshold (Ct) values from both the runs was compared using Bland-Altman (BA) analysis. Results: The positivity rates of rRT-PCR in NTS, saliva and gargle lavage samples were 82.7 (24/29), 79.3 (23/29) and 86.2 per cent (25/29), respectively. BA plot showed a good agreement between the Ct values of fresh and stored gargle samples, stipulating that there were no significant differences in the approximate viral load levels between the fresh and stored gargle lavage samples (bias: E gene -0.64, N gene -0.51, ORF gene -0.19). Interpretation & conclusions: Our study results show stability of SARS-CoV-2 RNA in the gargle samples collected using normal saline up to 24-30 h. Gargle lavage and saliva specimen collection are cost-effective and acceptable methods of sampling for the detection of SARS-CoV-2 RNA by rRT-PCR. These simplified, inexpensive and acceptable methods of specimen collection would reduce the cost and workload on healthcare workers for sample collection.

An open-label non-inferiority randomised control trial comparing nebulised amphotericin B with oral itraconazole in patients with pulmonary aspergilloma.

BACKGROUND: Pulmonary aspergilloma (PA) is a common complication seen in patients with pulmonary tuberculosis sequelae. Antifungal therapy, including oral azoles, is commonly used though only surgical resection offers curative benefit. Local administration of amphotericin B, like intracavitary instillation, has been effective in aspergilloma patients though nebulised amphotericin B (nAB) has never been formally assessed. OBJECTIVE: The aim of this prospective, non-inferior, open-label, randomised control trial is to evaluate the efficacy and safety of nebulised amphotericin B compared to oral itraconazole therapy in the treatment of PA. PATIENTS/METHODS: Diagnosed cases of PA (n=33) were randomised into the control group receiving oral itraconazole (n=18) and intervention group receiving nebulised amphotericin B (n = 15). Response to treatment was assessed both clinically and radiologically at the end 6 months. RESULTS AND CONCLUSION: The number of patients showing overall improvement at the end of 6 months in the control arm(oral itraconazole) vs intervention arm(nebulised amphotericin B) was 65% (95% CI 38.3-85.8) and 67%(95% CI 38.4%-88.2%), respectively, in the intention-to-treat and 79% (95% CI 49.2%-95.3%), and 65% (95% CI 38.4%-88.2%), respectively, in the per-protocol analysis. While there was no statistically significant difference between the intervention and control arm in both the analyses, non-inferiority was shown in the per-protocol but not in the intention-to-treat analysis. No major adverse events were noted in either group; however, a significant proportion of patients receiving nAB reported minor cough (40%), which, however, did not lead to discontinuation of therapy in any patients. Nebulised amphotericin B can be an effective therapeutic option for pulmonary aspergilloma patients.