ABSTRACT
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.
ABSTRACT
Background: The impact of the first wave of the pandemic due to SARS-CoV-2 has been enormous in Spanish hospitals, being Madrid one of the most affected communities. The aim of this study was to analyze the impact of the pandemic on the workers of a hospital located in one of the most affected areas of Madrid (Alcala de Henares) using a chemiluminescence immunoassay (CLIA). Methods: We conducted a seroprevalence survey between June 25th and July 31st, 2020, over hospital workers from our institution. This study population was previously analyzed using a diagnostic approach which consisted of PCR and a serologic rapid test. For the present survey, prevalence of IgG antibodies against SARS-CoV-2 was studied using chemiluminescence. We analyzed the prevalence in healthcare workers (HCW) and non-healthcare workers (nHCW). Information about professional category, use of personal protective equipment (PPEs) and previous COVID-19 contacts was collected to determine the risk factors associated with SARS-CoV-2 seropositivity. Comparisons were made using the Mann-Whitney U test (continuous variables) and the two-tailed Fisher's exact test (categorical variables). Risk factors for seropositivity were analyzed using multivariate logistic regression. Results: A total of 2,219 workers were included and 847 of them (38.2%) presented IgG antibodies against SARS-CoV-2, being seroprevalence significantly higher for HCW (39.3%) than for nHCW (30.7%, p=0.006). We found no differences regarding positivity rates compared with the first diagnostic approach for symptomatic and asymptomatic workers, or infected workers per professional category. In the multivariate logistic regression analysis, the use of PPE (protective, OR=0.65;95%CI: 0.48-0.89;p<0.001) and previous contact with COVID-19 patients (risk factor, OR=1.93;95%CI: 1.37-2.72;p<0.001) were independent factors that were associated with SARS-CoV-2 seropositivity. Conclusions: More than 38% of our workers presented IgG antibodies against SARS-CoV-2. We found no differences in the positivity rates between diagnostic approaches. The use of PPE (protective) and previous contact with COVID-19 patients (risk factor) were associated with infection.