High-Dose Dexamethasone Versus Tocilizumab in Moderate to Severe COVID-19 Pneumonia: A Randomized Controlled Trial.

Background and objectives Recent randomized controlled trials (RCTs) have indicated potential therapeutic benefits with high-dose dexamethasone (HDD) or tocilizumab (TCZ) plus standard care in moderate to severe coronavirus disease 2019 (COVID-19) with acute respiratory distress syndrome (ARDS). No study has compared these two against each other. We aimed to compare the efficacy and safety of HDD against TCZ in moderate to severe COVID-ARDS. Methods Patients admitted with moderate to severe COVID-19 ARDS with clinical worsening within 48 hours of standard care were randomly assigned to receive either HDD or TCZ plus standard care. The primary outcome was ventilator-free days (VFDs) at 28 days. The main secondary outcomes were 28-day all-cause mortality and the incidence of adverse events. Our initial plan was to perform an interim analysis of the first 42 patients. Results VFDs were significantly lower in the HDD arm (median difference: 28 days; 95% confidence interval (CI): 19.35-36.65; Cohen's d = 1.14;p < 0.001). We stopped the trial at the first interim analysis due to high 28-day mortality in the HDD arm (relative risk (RR) of death: 6.5; p = 0.007; NNT (harm) = 1.91). The incidence of secondary infections was also significantly high in the HDD arm (RR: 5.5; p = 0.015; NNT (harm) = 2.33). Conclusions In our study population, HDD was associated with a very high rate of mortality and adverse events. We would not recommend HDD to mitigate the cytokine storm in moderate to severe COVID-19 ARDS. TCZ appears to be a much better and safer alternative.

Performance of Health Care Workers in Doffing of Personal Protective Equipment Using Real-Time Remote Audio-Visual Doffing Surveillance System: Its Implications for Bio-Safety Amid COVID-19 Pandemic.

Background Very little has been reported about health care workers' (HCWs) adherence to the Centers for Disease Control and Prevention (CDC) guidelines of doffing personal protective equipment (PPE) amid the COVID-19 pandemic. Real-time remote audio-visual doffing surveillance (RADS) system for assisting doffing might reduce the risk of self-contamination. We used this system to determine the incidence of the breach in biosafety during doffing of PPE among HCWs involved in the care of Covid-19 patients. Methods A total of 100 HCWs were enrolled in this observational study who performed duties in the COVID intensive care unit (ICU) of our tertiary care centre. With a real-time RADS system, trained observers from remote locations assisted HCWs during doffing of PPE and noted breach at any step using the CDC doffing checklist. The breach was considered major if committed during removal of gloves/gown/N-95 or if ≥3 errors occurred in any other steps. Results Overall, 40% of the HCWs committed a breach during doffing at least one step. The majority of the errors were observed during hand hygiene (34%), followed by glove removal (12%) and N-95 removal (8%). Nineteen percent of HCWs committed the major breach, out of which 37.5% were done by house-keeping sanitation staff (p = 0.008 and RR 2.85; 95% CI of 1.313-6.19), followed by technicians (22.5%), nursing staff (16.7%) and resident doctors (6.5%). Conclusions Performing doffing using a real-time RADS system is associated with a relatively low incidence of a breach in biosafety compared with earlier studies using an onsite standard observer. Overall adherence of HCWs to the CDC guidelines of doffing PPE was satisfactory. This study highlights the importance of the RADS system during doffing of PPE in a health care setting amid the COVID-19 pandemic.

Pulmonary Function, Mental and Physical Health in Recovered COVID-19 Patients Requiring Invasive Versus Non-invasive Oxygen Therapy: A Prospective Follow-Up Study Post-ICU Discharge.

Background Survivors of COVID-19 pneumonia may have residual lung injury and poor physical and mental health even after discharge. We hypothesized that COVID-19 severe acute respiratory distress syndrome (ARDS) patients needing mechanical ventilation may be at a greater risk of deterioration in pulmonary function, mental health, and quality of life (QOL). This study analyses the differences in pulmonary function, mental health, and QOL after recovery, in patients having received non-invasive oxygen therapy versus invasive mechanical ventilation during ICU stay. Methods Patients aged >18 years, who had completed 3 months post ICU discharge, with moderate to severe COVID-19 ARDS, were consecutively enrolled from May 1 to July 31, 2021. Patients were allocated into Group A - having required high flow nasal cannula (HFNC)/non-invasive ventilation (NIV) and Group B - having received invasive mechanical ventilation. Pulmonary function tests, 6-minute walk test (6-MWT), and health-related quality of life were compared. Results Of the 145 eligible patients, 31 were lost to follow-up and 21 died. Seventy-four patients were allocated into Groups A (57 patients) and B (17 patients). In Group A, abnormal forced expiratory volume in first second (FEV1), forced vital capacity (FVC), forced expiratory flow in mid-half of FVC (FEF25-75), and peak expiratory flow rate (PEFR) values were obtained in 27 (47.37%), 43 (75.44%), 11 (19.3%), and 25 (43.86%) patients, and in Group B, in 13 (76.47%), 17 (100%), 1 (5.88%), and 8 (47%) patients, respectively. No patient had abnormal FEV1/FVC. All Group B patients had a restrictive pattern in spirometry as compared to 77% in Group A. Group B had a lower arterial partial pressure of oxygen (PaO2) (p=0.0019), % predicted FVC (p<0.0001), % predicted FEV1 (p=0.001), and 6-MWT distance (p<0.001). The physical component score in the short-form survey 12 questionnaire was higher in group A, p<0.001, whereas the mental component score was comparable. Conclusions Patients requiring invasive mechanical ventilation (MV) have a greater risk of impaired pulmonary function and reduced QOL post-ICU discharge. This warrants a greater need for following these patients for better rehabilitation.

High Prevalence of Hypocalcemia in Non-severe COVID-19 Patients: A Retrospective Case-Control Study.

Purpose: To compare serum total calcium and phosphate levels in patients with non-severe COVID-19 with age, sex, and serum 25-hydroxyvitamin D level matched healthy adult cohort. Methods: In this retrospective case-control study, medical records of patients (≥18 years) diagnosed as non-severe COVID-19 admitted at and discharged from our tertiary care institution during the period from April 10, 2020 and June 20, 2020 were retrieved. Baseline investigations, notably, serum calcium, phosphate, albumin, magnesium, 25-hydroxyvitamin D, and C-reactive protein (CRP), were performed at admission before any form of calcium or vitamin D supplementation were considered. The biochemical parameters were compared with age, sex, and 25-hydroxyvitamin D matched healthy adult controls (1:1 ratio) derived from the Chandigarh Urban Bone Epidemiological Study (CUBES). Results: After exclusion, 72 patients with non-severe COVID-19 (63 mild and 9 moderate disease) and an equal number of healthy controls were included in the final analysis. Age, sex, serum 25-hydroxyvitamin D, and albumin levels were matched between the 2 groups. Hypovitaminosis D and hypocalcemia were seen in 97 and 67% of the patients, respectively. The patients had lower serum calcium (P value <0.001) and phosphate (P = 0.007) compared with the controls. There was no statistically significant correlation between serum calcium and CRP. Conclusions: Hypocalcemia is highly prevalent even in COVID-19 patients with non-severe disease probably implying that hypocalcemia is intrinsic to the disease. Prospective studies with larger number of patients are required to prove this hypothesis and unravel the underlying pathophysiological mechanisms.