Efficacy of colchicine in patients with moderate COVID-19: A double-blinded, randomized, placebo-controlled trial.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may cause severe life-threatening diseases called acute respiratory distress syndrome (ARDS) owing to cytokine storms. The mortality rate of COVID-19-related ARDS is as high as 40% to 50%. However, effective treatment for the extensive release of acute inflammatory mediators induced by hyperactive and inappropriate immune responses is very limited. Many anti-inflammatory drugs with variable efficacies have been investigated. Colchicine inhibits interleukin 1 beta (IL-1ß) and its subsequent inflammatory cascade by primarily blocking pyrin and nucleotide-binding domain leucine-rich repeat and pyrin domain containing receptor 3 (NLRP3) activation. Therefore, this cheap, widely available, oral drug might provide an added benefit in combating the cytokine storm in COVID-19. Here, we sought to determine whether adding colchicine to other standards of care could be beneficial for moderate COVID-19 pneumonia in terms of the requirement for advanced respiratory support and mortality. METHODS AND FINDINGS: This blinded placebo-controlled drug trial was conducted at the Dhaka Medical College Hospital, Dhaka, Bangladesh. A total of 300 patients with moderate COVID-19 based on a positive RT-PCR result were enrolled based on strict selection criteria from June 2020 to November 2020. Patients were randomly assigned to either treatment group in a 1:1 ratio. Patients were administered 1.2 mg of colchicine on day 1 followed by daily treatment with 0.6 mg of colchicine for 13 days or placebo along with the standard of care. The primary outcome was the time to clinical deterioration from randomization to two or more points on a seven-category ordinal scale within the 14 days post-randomization. Clinical outcomes were also recorded on day 28. The primary endpoint was met by 9 (6.2%) patients in the placebo group and 4 (2.7%) patients in the colchicine group (P = 0.171), which corresponds to a hazard ratio (95% CI) of 0.44 (0.13-1.43). Additional analysis of the outcomes on day 28 revealed significantly lower clinical deterioration (defined as a decrease by two or more points) in the colchicine group, with a hazard ratio [95%CI] of 0.29 [0.098-0.917], (P = 0.035). Despite a 56% reduction in the need for mechanical ventilation and death with colchicine treatment on day 14, the reduction was not statistically significant. On day 28, colchicine significantly reduced clinical deterioration measured as the need for mechanical ventilation and all-cause mortality. CONCLUSION: Colchicine was not found to have a significant beneficial effect on reducing mortality and the need for mechanical ventilation. However, a delayed beneficial effect was observed. Therefore, further studies should be conducted to evaluate the late benefits of colchicine. CLINICAL TRIAL REGISTRATION: Clinical trial registration no: ClinicalTrials.gov Identifier: NCT04527562 https://www.google.com/search?client=firefox-b-d&q=NCT04527562.

Hyponatremia in COVID-19 patients: Experience from Bangladesh.

Background: The purpose of the study was to measure the prevalence of hyponatremia and its association with clinical and laboratory characteristics of hospitalized coronavirus disease 2019 (COVID-19) patients at Dhaka Medical College and Hospital (DMCH). Methods: This retrospective study was conducted in COVID-19 dedicated wards at DMCH from June to August 2020. Demographic, clinical, and laboratory data were collected from patient treatment sheets. Two groups of COVID-19 patients were retrospectively screened on the basis of plasma sodium level at admission: hyponatremic (sodium < 135 mM, n = 84) or normonatremic (sodium ≥ 135 mM, n = 48) patients. Severity was assessed using World Health Organization classification for COVID-19 disease severity. To compare the two groups, Pearson's χ 2 (qualitative variables) and Student's T tests (quantitative variables) were applied. The link between patients' clinical data and outcomes was investigated using logistic regression model. Results: A total of 132 patients were included in the study, with a mean age of 51.41 (±14.13) years. Hyponatremia was found in 84 patients (63.6%) and the remaining 48 patients (36.4%) had normal plasma Na+ values. Among them, 74 (56.06%) presented with severe disease and 53 (40.15%) with moderate disease. At presentation, patients with moderate COVID-19 disease had 2.15 (1.04-4.5) times higher odds of suffering from hyponatremia. Besides, hyponatremia was independently associated with on admission SpO2 (p = 0.038), hemoglobin (p = 0.004), and C-reactive protein (p = 0.001). Conclusions: The authors suggest that patients' serum electrolytes be measured during initial hospital admission and then monitored throughout the hospital stay to predict the probability for referral for invasive ventilation and for better management.

Persistence of sleep disturbance among post-COVID patients: Findings from a 2-month follow-up study in a Bangladeshi cohort.

To evaluate the persistence and factors associated with sleep disturbances among COVID-19 patients with a history of sleep disturbances 2 months after discharge from the hospital. A total of 400 patients admitted at Dhaka Medical College Hospital during July and August were diagnosed as suffering from sleep disturbances during their hospital stay using a standardized scale. They were followed up 2 months later through telephone, and a total of 322 participants were interviewed (excluding 63 nonresponders and five deceased) regarding the persistence of disturbances in sleep through a structured questionnaire. Patient demographic, clinical, and epidemiological data including history regarding in-hospital sleep disturbance were retrieved from hospital treatment sheets. Results revealed, 35% of study participants (n = 113) were still experiencing symptoms of sleep disturbances during the interview by telephone. Age (p = 0.015), diabetes mellitus (relative risk [RR]: 1.21; confidence interval [CI]: 1.02-1.42, p = 0.022), on admission SPO2 (p = 0.009), C-reactive protein (CRP) (p = 0.025), serum ferritin (p = 0.014), and d-dimer (p = 0.030) were independently associated with sleep disturbances among participants (p < 0.05). Binary and fitting logistic regression through repeated K folds cross-validation revealed 1.65 (CI: 1.02-2.66), 1.07 (CI: 1.01-1.14), and 1.07 (CI: 1.00-1.15) times higher odds of persistence of sleep disturbances among patients with diabetes mellitus, increased neutrophil, and lymphocyte percentages, respectively. Findings of this study need to be validated and patients should be further followed up with more in-depth studies conducted 6 or 12 months after initial infection, possibly with the help of higher sample size and in-person interview.

A 2‐month post‐COVID‐19 follow‐up study on patients with dyspnea

Background and aims Dyspnea is one of the most common symptoms associated with the COVID‐19 caused by novel coronavirus SARS‐CoV‐2. This study aimed to assess the prevalence of dyspnea, observe co‐variables, and find predictors of dyspnea after 2 months of recovery from COVID‐19. Methods A total of 377 patients were included in the study based on their responses and clinical findings during initial admission to the hospital with COVID‐19. After excluding five deceased patients, a total of 327 patients were interviewed through telephone using a 12‐point dyspnea scale and using relevant questions to gauge the patient clinically. Interviews were carried out by trained physicians, and responses were recorded and stored. All analyses were carried out using the statistical programming language R. Results Of the total 327 participants in the study, 34% had stated that they were suffering from respiratory symptoms even after 2 months of COVID‐19. The study demonstrated that patient oxygen saturation level SpO2 (P = .03), D‐dimer (P = .001), serum ferritin (P = .006), and the presence and severity of dyspnea are significantly correlated. In addition to that, patient smoking history (P = .012) and comorbidities such as chronic obstructive pulmonary disease (COPD) (P = .021) were found to be statistically significant among groups. Conclusion These findings of this study can be useful for predicting and managing long‐term complications of COVID‐19.

A 2-month post-COVID-19 follow-up study on patients with dyspnea.

BACKGROUND AND AIMS: Dyspnea is one of the most common symptoms associated with the COVID-19 caused by novel coronavirus SARS-CoV-2. This study aimed to assess the prevalence of dyspnea, observe co-variables, and find predictors of dyspnea after 2 months of recovery from COVID-19. METHODS: A total of 377 patients were included in the study based on their responses and clinical findings during initial admission to the hospital with COVID-19. After excluding five deceased patients, a total of 327 patients were interviewed through telephone using a 12-point dyspnea scale and using relevant questions to gauge the patient clinically. Interviews were carried out by trained physicians, and responses were recorded and stored. All analyses were carried out using the statistical programming language R. RESULTS: Of the total 327 participants in the study, 34% had stated that they were suffering from respiratory symptoms even after 2 months of COVID-19. The study demonstrated that patient oxygen saturation level SpO2 (P = .03), D-dimer (P = .001), serum ferritin (P = .006), and the presence and severity of dyspnea are significantly correlated. In addition to that, patient smoking history (P = .012) and comorbidities such as chronic obstructive pulmonary disease (COPD) (P = .021) were found to be statistically significant among groups. CONCLUSION: These findings of this study can be useful for predicting and managing long-term complications of COVID-19.