ABSTRACT
To assess long-term clinical, radiological, and functional follow-up of patients hospitalized for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pneumonia of different grades of severity. Two-hundred-thirty and three patients (Group 1, patients needed invasive mechanical ventilation, n = 69; Group 2, patients needed noninvasive mechanical ventilation, n = 78; Group 3, patients needed <12 L/min of O2 supply, n = 96) with a postdischarge follow-up >12 months were studied. Follow-up visits, chest computed tomography (CT) scan and pulmonary function tests (diffusing capacity of the lung for carbon monoxide [DLCO], 6-min walking tests [6MWT], spirometry) were done at 3, 6, and 12 months after discharge. Male sex was more frequent in Group 1 (n = 50, 72.5%) compared with Group 2 (n = 49, 62.5%) and Group 3 (n = 44, 51.2%), p = 0.024. Group 2 patients had more comorbidities and higher BMI compared with others. At Month 12, the main reported symptoms were fatigue (mainly in Group 3) and dyspnea; most symptoms resolved during follow-up, except brain fog, memory loss, and anosmia/dysgeusia that, when present at Month 3, usually persisted at Month 12. DLCO and 6MWT normalized at Month 12 in almost all patients. Only nine patients (13%) in Group 1 had a normal chest CT at Month 12, while 20 (29%) had >3 abnormalities, compared with 14 (17.9%) in Group 2 and 11 (11.4%) in Group 3, respectively (p = 0.04). Different clinical symptoms persist up to 12 months in patients hospitalized for SARS-CoV-2 pneumonia. Despite the persistence of abnormalities at chest CT scan after 12 months, an impairment of pulmonary function persists only in a minority of subjects. A longer follow-up is needed to assess the evolution of radiological abnormalities in COVID-19 population.
Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Male , Aftercare , Patient Discharge , LungABSTRACT
BACKGROUND: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate the efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period. METHODS: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400 mg of hydroxychloroquine daily for the first four consecutive days and subsequently, 400 mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. RESULTS: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Given the national epidemic incidence decay, only one participant in each group was diagnosed with COVID-19. The trial was stopped due to futility and our study design was deemed underpowered to evaluate any benefit regarding PrEP efficacy. Both groups showed a similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). CONCLUSIONS: Although the efficacy of PrEP with hydroxychloroquine for preventing COVID-19 could not be evaluated, our study showed that PrEP with hydroxychloroquine at low doses is safe. TRIAL REGISTRATION: ClinicalTrials.gov NCT04331834 . Registered on April 2, 2020.