Clinical outcomes and quality of life of COVID-19 survivors: A follow-up of 3 months post hospital discharge.

BACKGROUND: Over 66 million people worldwide have been diagnosed with COVID-19. Therefore, understanding their clinical evolution beyond hospital discharge is essential not only from an individual standpoint, but from a populational level. OBJECTIVES: Our primary aim was to assess the impact of COVID-19 on health-related quality of life (HRQoL) 3 months after hospital discharge. Additionally, we screened for anxiety and depression and assessed important clinical outcomes. METHODS: This was a single-center cohort study performed in Sao Paulo (Brazil), in which participants were contacted by telephone to answer a short survey. EQ-5D-3L was used to assess HRQoL and clinical data from patients' index admission were retrieved from medical records. RESULTS: We contacted 251 participants (59.8% males, mean age 53 years old), 69.7% of which had presented with severe COVID-19. At 3 months of follow-up, 6 patients had died, 51 (20.3%) had visited the emergency department again and 17 (6.8%) had been readmitted to hospital. Seventy patients (27.9%) persisted with increased dyspnoea and 81 had a positive screening for anxiety/depression. Similarly, patients reported an overall worsening of EQ-5D-3L single summary index at 3 months compared to before the onset of COVID-19 symptoms (0.8012 (0.7368 - 1.0) vs. 1.0(0.7368 - 1.0), p < 0.001). This affected all 5 domains, but especially pain/discomfort and anxiety/depression. Only female sex and intensive care requirement were independently associated with worsening of HRQoL. CONCLUSION: Patients hospitalized for COVID-19 frequently face persistent clinical and mental health problems up to 3 months following hospital discharge, with significant impact on patients' HRQoL.

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.