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Article

Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial

1
Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain
2
Spanish Clinical Research Network (SCReN), 28046 Madrid, Spain
3
Internal Medicine Department, Infanta Sofía University Hospital, 28702 San Sebastián de los Reyes, Spain
4
Internal Medicine Department, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
5
Sleep Unit, Hospital General Universitario de Castellón, 12004 Castellón de la Plana, Spain
6
Internal Medicine/Infectious Diseases Department, Hospital Clínico San Carlos, IdiSSC, 28040 Madrid, Spain
7
Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), 28041 Madrid, Spain
8
Infectious Diseases Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain
9
Emergency Department, Infanta Sofía University Hospital, 28702 San Sebastián de los Reyes, Spain
10
Preventive Medicine Unit, Infanta Sofia University Hospital, 28702 San Sebastián de los Reyes, Spain
11
Pediatric Department, Infanta Sofia University Hospital, 28702 San Sebastián de los Reyes, Spain
12
School of Medicine, Universidad Autónoma de Madrid, 28029 Madrid, Spain
13
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), 28029 Madrid, Spain
14
Pediatric Intensive Care Department, La Paz University Hospital-IdiPAZ, Paseo de la Castellana, 261, 28046 Madrid, Spain
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editors: Pierachille Santus and Michela Sabbatucci
J. Clin. Med. 2022, 11(4), 1139; https://doi.org/10.3390/jcm11041139
Received: 14 January 2022 / Revised: 29 January 2022 / Accepted: 18 February 2022 / Published: 21 February 2022
(This article belongs to the Collection Practice and Research in Clinical Pharmacology)
We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomised 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. The main outcome was the number of SARS-CoV-2 infections. A total of 344 volunteers were screened, and 314 were randomised: 151 to placebo and 163 to melatonin; 308 received the study treatment (148 placebo; 160 melatonin). We detected 13 SARS-CoV-2 infections, 2.6% in the placebo arm and 5.5% in the melatonin arm (p = 0.200). A total of 294 adverse events were detected in 127 participants (139 in placebo; 155 in melatonin). We found a statistically significant difference in the incidence of adverse events related to treatment: 43 in the placebo arm and 67 in the melatonin arm (p = 0.040), and in the number of participants suffering from somnolence related to treatment: 8.8% (n = 14) in the melatonin versus 1.4% (n = 2) in the placebo arm (p = 0.008). No severe adverse events related to treatment were reported. We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers. View Full-Text
Keywords: SARS-CoV-2; melatonin; prophylaxis; COVID-19; healthcare workers SARS-CoV-2; melatonin; prophylaxis; COVID-19; healthcare workers
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MDPI and ACS Style

García-García, I.; Seco-Meseguer, E.; Ruiz-Seco, P.; Navarro-Jimenez, G.; Martínez-Porqueras, R.; Espinosa-Díaz, M.; Ortega-Albás, J.J.; Sagastagoitia, I.; García-Morales, M.T.; Jiménez-González, M.; Martínez de Soto, L.; Bajo-Martínez, A.I.; del Palacio-Tamarit, M.; López-García, R.; Díaz-García, L.; Queiruga-Parada, J.; Giesen, C.; Pérez-Villena, A.; de Castro-Martínez, M.; González-García, J.J.; Rodriguez-Rubio, M.; de la Oliva, P.; Arribas, J.R.; Carcas, A.J.; Borobia, A.M. Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial. J. Clin. Med. 2022, 11, 1139. https://doi.org/10.3390/jcm11041139

AMA Style

García-García I, Seco-Meseguer E, Ruiz-Seco P, Navarro-Jimenez G, Martínez-Porqueras R, Espinosa-Díaz M, Ortega-Albás JJ, Sagastagoitia I, García-Morales MT, Jiménez-González M, Martínez de Soto L, Bajo-Martínez AI, del Palacio-Tamarit M, López-García R, Díaz-García L, Queiruga-Parada J, Giesen C, Pérez-Villena A, de Castro-Martínez M, González-García JJ, Rodriguez-Rubio M, de la Oliva P, Arribas JR, Carcas AJ, Borobia AM. Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial. Journal of Clinical Medicine. 2022; 11(4):1139. https://doi.org/10.3390/jcm11041139

Chicago/Turabian Style

García-García, Irene, Enrique Seco-Meseguer, Pilar Ruiz-Seco, Gema Navarro-Jimenez, Raúl Martínez-Porqueras, María Espinosa-Díaz, Juan J. Ortega-Albás, Iñigo Sagastagoitia, María T. García-Morales, María Jiménez-González, Lucía Martínez de Soto, Ana I. Bajo-Martínez, María del Palacio-Tamarit, Raquel López-García, Lucía Díaz-García, Javier Queiruga-Parada, Christine Giesen, Ana Pérez-Villena, Marta de Castro-Martínez, Juan J. González-García, Miguel Rodriguez-Rubio, Pedro de la Oliva, José R. Arribas, Antonio J. Carcas, and Alberto M. Borobia. 2022. "Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial" Journal of Clinical Medicine 11, no. 4: 1139. https://doi.org/10.3390/jcm11041139

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