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Objective: To evaluate the efficacy of melatonin as a prophylactic treatment on prevention of symptomatic SARSCoV- 2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Material and/or methods: In April 2020 we designed a two-arm parallel randomized double-blind controlled trial. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomized 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. Study visits: Screening (D1), Week 4, 8 and 12. A follow-up phone call was performed 4 weeks after the last intake of the study drug. The main outcome was the number of SARS-CoV-2 symptomatic infections (COVID-19) confirmed by polymerase chain reaction (PCR) or serologic test or according to each centre diagnosis protocol. During the study, participants should daily enter in an online application data concerning treatment administration, adverse events, food intake, exercise, sleeping hours and other data related to the effects of melatonin. Also, participants were asked to fulfil the Pittsburgh Sleep Quality Index (PSQI) at screening and at the 12 week visit. Results: A total of 344 volunteers were screened, mean age was 40.1 (10.8) years and most of them were females (80.8%). Three hundred fourteen were randomized (151 placebo;163 melatonin) and 308 received the study treatment (148 placebo;160 melatonin). We detected 13 SARS-CoV-2 symptomatic infections during the follow-up, 2.6% in the placebo arm (n = 4/151) and 5.5% in the melatonin arm (n = 9/163) (p = 0.2). A total of 124 participants had at least one adverse event. A total of 304 adverse events were detected. No severe adverse events related to treatment were reported. Conclusions: We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in high-risk contacts (hospital staff). Other safety and efficacy data, PSQI data and data obtained from the online application fulfilled by the participants will be soon analysed.
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BACKGROUND AND PURPOSE: Ischaemic stroke has been described in association with COVID-19. Several pathophysiological mechanisms have been suggested, i.e. prothrombotic state, cardiac injury etc. It was sought to assess the potential association between ischaemic stroke associated with SARS-CoV-2 infection and underlying atherosclerotic lesions. METHODS: A retrospective analysis of stroke related to large vessel occlusion was conducted amongst patients with SARS-CoV-2 infection and underlying mild atherosclerotic disease, between 19 March and 19 April 2020 in six different stroke centers in the Île-de France area, France. RESULTS: The median age was 52 years, median body mass index was 29.5 kg/m2 . All patients displayed previous vascular risk factors such as high blood pressure, diabetes, dyslipidemia or body mass index > 25. The delay between the first respiratory symptoms of COVID-19 and stroke was 11.5 days. At baseline, all had tandem occlusions, i.e. intracerebral and extracerebral thrombus assessed with computed tomography or magnetic resonance imaging. Cases displayed a large thrombus in the cervical carotid artery with underlying mild non-stenosing atheroma, after an etiological workup based on angio-computed tomography or magnetic resonance imaging and/or cervical echography. CONCLUSION: Our study should alert clinicians to scrutinize any new onset of ischaemic stroke during COVID-19 infection, mainly in patients with vascular risk factors or underlying atherosclerotic lesions.