TY - JOUR
T1 - Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID)
T2 - A Randomised Clinical Trial
AU - García-García, Irene
AU - Seco-Meseguer, Enrique
AU - Ruiz-Seco, Pilar
AU - Navarro-Jimenez, Gema
AU - Martínez-Porqueras, Raúl
AU - Espinosa-Díaz, María
AU - Ortega-Albás, Juan José
AU - Sagastagoitia, Iñigo
AU - García-Morales, María Teresa
AU - Jiménez-González, María
AU - Soto, Lucía Martínez de
AU - Bajo-Martínez, Ana Isabel
AU - Palacio-Tamarit, María Del
AU - López-García, Raquel
AU - Díaz-García, Lucía
AU - Queiruga-Parada, Javier
AU - Giesen, Christine
AU - Pérez-Villena, Ana
AU - Castro-Martínez, Marta de
AU - González-García, Juan J.
AU - Rodriguez-Rubio, Miguel
AU - de la Oliva, Pedro
AU - Arribas, José R.
AU - Carcas, Antonio J.
AU - Borobia, Alberto M.
N1 - Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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.
AB - 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.
KW - COVID-19
KW - Healthcare workers
KW - Melatonin
KW - Prophylaxis
KW - SARS-CoV-2
UR - https://www.scopus.com/pages/publications/85124980607
U2 - 10.3390/jcm11041139
DO - 10.3390/jcm11041139
M3 - Article
AN - SCOPUS:85124980607
SN - 2077-0383
VL - 11
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
IS - 4
M1 - 1139
ER -