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Coronavirus disease-2019 (COVID-19) is prone to acute hypoxemic respiratory failure (AHRF). Because tracheal intubation is associated with a higher risk of death in these patients, AHRF employs high-flow nasal oxygen therapy (HFNOT). The goal of this study was to assess the effect of HFNOT on oxygenation status as well as different predictors of HFNOT failure.A prospective observational cohort study was conducted in COVID-positive critically ill adult patients (age18 years) with AHRF, who were unable to maintain SpOA total of 114 patients were enrolled in the study, with an HFNOT failure rate of 29%. The median PaOThe use of HFNOT significantly increased the oxygenation levels in COVID-19 patients with AHRF at various time periods after HFNOT beginning. Age, SOFA score, APACHE II score, ROX score, admission P/F ratio, IL-6, D-dimer, and RBS were independent prognostic factors of HFNOT failure in this cohort.Khan MS, Prakash J, Banerjee S, Bhattacharya PK, Kumar R, Nirala DK. High-flow Nasal Oxygen Therapy in COVID-19 Critically Ill Patients with Acute Hypoxemic Respiratory Failure: A Prospective Observational Cohort Study. Indian J Crit Care Med 2022;26(5):596-603.

PURPOSE: We assessed long-term outcomes of dexamethasone 12 mg versus 6 mg given daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia.METHODS: We assessed 180-day mortality and health-related quality of life (HRQoL) using EuroQoL (EQ)-5D-5L index values and EQ visual analogue scale (VAS) in the international, stratified, blinded COVID STEROID 2 trial, which randomised 1000 adults with confirmed COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 26 hospitals in Europe and India. In the HRQoL analyses, higher values indicated better outcomes, and deceased patients were given a score of zero.RESULTS: We obtained vital status at 180 days for 963 of 982 patients (98.1%) in the intention-to-treat population, EQ-5D-5L index value data for 922 (93.9%) and EQ VAS data for 924 (94.1%). At 180 days, 164 of 486 patients (33.7%) had died in the 12 mg group versus 184 of 477 (38.6%) in the 6 mg group [adjusted risk difference - 4.3%; 99% confidence interval (CI) - 11.7-3.0; relative risk 0.89; 0.72-1.09; P = 0.13]. The adjusted mean differences between the 12 mg and the 6 mg groups in EQ-5D-5L index values were 0.06 (99% CI - 0.01 to 0.12; P = 0.10) and in EQ VAS scores 4 (- 3 to 10; P = 0.22).CONCLUSION: Among patients with COVID-19 and severe hypoxaemia, dexamethasone 12 mg compared with 6 mg did not result in statistically significant improvements in mortality or HRQoL at 180 days, but the results were most compatible with benefit from the higher dose.

Background and aim The management of the worldwide spreading COVID-19 consists of amelioration of its symptoms but no cure is yet available. Herbal medicines supplemented with the Western medicine have been applied for COVID-19 treatment in India, China, Iran, and other countries. This systematic review and meta-analysis of RCTs evaluates the effect and safety of herbal intervention in the management of COVID-19. Experimental procedure RCTs from databases like PubMed, Cochrane Library, ScienceDirect, Google Scholar, Science Direct, CTRI, AYUSH Research Portal, India, were reviewed and the data were extracted for study sample demographics, intervention details, clinical effect, inflammatory markers and safety monitoring. Outcomes were expressed as Risk-ratio (RR) with 95% CI for dichotomous data, and Mean-Difference (MD) with 95% CI for continuous data. Result and conclusion From the 32 eligible studies, a total of 3177 COVID-19 patients were included in the review. Herbal intervention as an adjuvant to Western medicine causes significantly higher improvement compared to Western medicine alone [Fever (RR = 1.09 CI 1.03, 1.15), Cough (Risk-Ratio = 1.22 CI 1.08, 1.37), Fatigue (Risk-Ratio = 1.27 CI 1.11, 1.44), Chest CT Improvement (Risk-Ratio = 1.15 CI 1.08, 1.23)]. The laboratory parameters were also better in the herbal medicine group compared to standard care group only WBC (MD = 0.36 CI 0.16, 0.55), Lymphocyte percentage (MD = 5.48 CI 3.05, 7.92), Absolute lymphocyte count (MD = 0.23 CI 0.07, 0.39), CRP (MD = −5.66 CI -7.96, −3.37). However, duration of hospital stays (MD = −1.82 CI -3.84, 0.21); IL-6 (MD = −3.67 CI -8.76, 1.43), ESR Level (MD = −10.38 CI -25.96, 5.21) were statistically insignificant. No significant adverse events for herbal medications were noted in the included RCTs, during the time of the studies. (n = 665, RR 0.93; 95% CI 0.76, 1.14)., Graphical abstract Image 1

Inosine pranobex (IP), an immunomodulatory agent, is used in the treatment of various viral infections. The results of a phase 3 randomized controlled trial are reported, evaluating the efficacy and safety of IP in the treatment of mild to moderate COVID-19. It includes 416 symptomatic patients with confirmed SARS-CoV-2 infection. In addition to a defined standard of care, patients randomly (1:1) receive either IP 500 mg tablet (IP group) or a matching placebo (placebo group) at 50 mg kg

BACKGROUND Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs lower doses of dexamethasone (12 vs 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia. METHODS This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors. DISCUSSION This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results. TRIAL REGISTRATION ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.

BACKGROUND The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear. METHODS The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol. DISCUSSION The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.

Context: Midazolam and propofol are effective sedatives for use in upper gastrointestinal endoscopy (UGIE); however, their utility is limited when used alone. In this regard, dexmedetomidine seems to be a promising sedative. Aims: The aim was to compare the hemodynamic effects and sedation efficacy of these drugs in patients undergoing elective diagnostic UGIE. Settings and Design: Randomized control double-blind study was conducted at a teaching hospital. Subjects and Methods: Patients belonging to ASA Grade I or II, undergoing diagnostic elective UGIE were enrolled in the study and randomized into three groups; Group I received midazolam infusion, Group II received propofol infusion and Group III received dexmedetomidine infusion. Hemodynamic parameters and adverse events were recorded during the procedure (intra-operative period [IOP]). Both patient and endoscopist satisfaction were rated on visual analog scale (0 = no pain/least difficulty to 10 = worst pain/maximum difficulty). Recovery was recorded as time to achieve modified Aldrete score of 10/10. Statistical Analysis: Parametric test analysis of variance was applied to compare the means of three groups of continuous data. Results: Ninety patients were analyzed. Mean arterial pressure was significantly lower in the propofol group at IOP2, IOP4, IOP8, and IOP10 compared with dexmedetomidine and midazolam group. The endoscopist satisfaction level was significantly higher in dexmedetomidine group as compared to propofol and midazolam (60%, 56.7%, 13.3%; P < 0.001). Significantly faster recovery was observed in dexmedetomidine group compared to midazolam and propofol group (7.7 ± 3.9, 18.3 ± 3.8, 12.7 ± 2.9 min; P = 0.001). Conclusions: Use of dexmedetomidine was associated with greater hemodynamic stability and faster recovery when compared to propofol and midazolam.

Context Sedation is commonly used to improve patients' tolerance and comfort during flexible bronchoscopy (FB). Dexmedetomidine is a relatively novel sedative for use in FB. Aims The aim of this study was to compare dexmedetomidine and propofol as sole sedative agent in terms of hemodynamics, efficacy, safety and tolerance to the procedure among patients undergoing FB. Settings and design This study was carried out in a tertiary care teaching hospital, and was a double-blind randomized-controlled trial. Patients and methods Sixty patients were analyzed. Group 1 received propofol (1 mg/kg bolus, then 5 mg/kg/h infusion); group 2 received dexmedetomidine (1 mg/kg bolus, followed by 0.7 mg/kg/h infusion). Intraoperative (IOP) SpO 2 , heart rate, mean arterial pressure, and respiratory rate were recorded at nine time points. Primary outcome variables were hemodynamic variables, level of sedation, and recovery time (to reach an Aldrete score 10/10). Results The dexmedetomidine group showed significantly lower mean heart rate than the propofol group at IOP 0 , IOP 2 , and IOP 4 . The mean arterial pressure was significantly higher throughout the procedure in the dexmedetomidine group compared with the propofol group ( P 4 and IOP 6 ( P 2 was noted in the dexmedetomidine group (97.0 ± 1.1). Incidences of bucking and coughing were significantly higher in the dexmedetomidine group. Bronchoscopist visual analogue scale scores for coughing and satisfaction were significantly lower in the propofol group ( P P < 0.001). Conclusion Propofol showed superiority over dexmedetomidine in terms of safety, efficacy, adverse-effect profile, and tolerance to the procedure in patients undergoing diagnostic flexible bronchoscopy.

Introduction Predictive accuracy of severity scoring systems in Indian ICUs does not fit well owing to differences in case mix from the west. We hypothesized that 24 h is too early to predict the outcome and that the predictive accuracy of these scores might be better at 48 h of ICU admission. Objective The aim of this study was to evaluate and compare Acute Physiology and Chronic Health Evaluation (APACHE) II, Simplified Acute Physiology (SAPS) II, and Sequential Organ Failure Assessment (SOFA) as a predictor of outcome in critically ill patients at 24 and at 48 h in a tertiary care hospital ICU. Patients and methods A prospective cohort study was conducted on 169 patients over 2 years at a single medical surgical ICU. Eighty-five critically ill patients were included. For each patient, APACHE II, SAPS II, and SOFA scores were calculated at two time frames (first at 24 and then at 48 h) after ICU admission. The accuracies and comparisons of outcome prediction by the three scores were assessed with standardized mortality ratio and area under the receiver operating characteristic (AUROC) curves. Results All scoring systems (except SOFA) underestimated the deaths (standardized mortality ratio>1). All scoring systems displayed larger AUROC curves at 48 h than those at 24 h. APACHE II 48 showed the largest AUROC of 0.933. Conclusion All scores performed better when calculated at 48 h rather than at 24 h. Overall, APACHE II 48 is the best predictor of 28-day mortality in critically ill patients. A worsening APACHE II score at 48 h after ICU admission may identify the patients at high risk of mortality.