Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial.

BACKGROUND: The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19. METHODS: We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278. FINDINGS: 447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups. INTERPRETATION: In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19. FUNDING: COALITION COVID-19 Brazil and EMS.

Restarting Elective Bariatric and Metabolic Surgery Under a Security Protocol During the COVID-19 Pandemic-a Prospective Observational Cohort Study.

BACKGROUND: During the SARS-CoV-2 pandemic, in order to protect the patient and to save hospital beds, cancelation of elective surgeries has become a great challenge. Considering that obesity is a chronic disease and the possible effect imposed by quarantine on weight gain with worsening rates of obesity and metabolic comorbidities, the creation of a protocol for a safe return to bariatric surgery became essential. OBJECTIVE: The aim of this study was to identify the incidence of new-onset severe acute respiratory syndrome coronavirus (SARS-CoV-2) symptoms in patients who underwent bariatric procedures during the declining curve period. SETTING: Private practice METHODS: A prospective observational cohort study was conducted and included patients with indications for bariatric surgery during the decreasing curve period of the SARS-CoV-2 pandemic who underwent surgery under a hospital security protocol. Patients were asked to answer a questionnaire and had a swab PCR test for SARS-CoV-2 detection. The primary outcome measure was the presence of 14-day and 30-day postoperative symptoms associated with COVID-19. Mortality was also analyzed. RESULTS: Three hundred patients with negative RT-PCR were operated on from May to June 2020. Seventeen patients had their surgery postponed because of a positive RT-PCR test or close contact. None of the patients developed new-onset SARS-CoV-2 symptomatic infection after 30 days of observation. No deaths were reported. Eleven had complications not related to SARS-CoV-2. CONCLUSIONS: Even though this population may have a poorer outcome when infected with SARS-CoV-2, this security protocol has shown that the procedure can be safely performed during the outbreak.

Low estimated glomerular filtration rate and chronic kidney failure following liver transplant: a retrospective cohort study.

BACKGROUND: Patients undergoing orthotropic liver transplant (LTx) often present with chronic kidney disease (CKD). Identification of patients who will progress to end-stage renal disease (ESRD) might allow not only the implementation of kidney protective measures but also simultaneous kidney transplant. STUDY DESIGN: Retrospective cohort study in adults who underwent LTx at a single center. ESRD, death, and composite of ESRD or death were studied outcomes. RESULTS: 331 patients, who underwent LTx, were followed up for 2.6 ± 1.4 years; 31 (10%) developed ESRD, 6 (2%) underwent kidney transplant after LTx and 25 (8%) remained on chronic hemodialysis. Patients with preoperative eGFR lesser than 60 ml/min per 1.73 m2 had a 4-fold increased risk of developing ESRD after adjustment for sex, diabetes mellitus, APACHE II score, use of nephrotoxic drugs, and severe liver graft failure (HR = 3.95, 95% CI 1.73, 9.01; p = 0.001). Other independent risk factors for ESRD were preoperative diabetes mellitus and post-operative severe liver graft dysfunction. CONCLUSION: These findings emphasize low eGFR prior to LTx as a predictor for ESRD or death. The consideration for kidney after liver transplant as a treatment modality should be taken into account for those who develop chronic kidney failure after LTx.