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Detalle de: A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care

Title A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care
Abstract

Introduction The clinical effect of domperidone against COVID-19 has been investigated in a double-blind phase III clinical trial (EudraCT number 2021-001228-17). Domperidone has shown in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential immudolatory properties through the stimulation of prolactin secretion. Patients and methods The efficacy of oral domperidone plus standard of care (SOC; n = 87) versus placebo plus SOC ( n = 86) was evaluated in a 28-day randomized double-blind multicentre study in primary health care centres. A total of 173 outpatients with mild-to-moderate COVID-19 were included. Three daily doses of 10 mg (30 mg/day) of domperidone or placebo were administered for 7 days. Reduction of viral load on day 4 was the primary efficay endpoint. It was estimated in saliva samples by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), as the cycle thresholds detected ORF1ab, N Protein and S Protein genes. Results A significant reduction in the viral load was observed ( p Conclusion Results do not prove the use of domperidone as antiviral in patients with COVID-19.

Apa Reference Rabanal Basalo, A., Navarro Pablos, M., Viejo Pinero, N., Vila Méndez, M.L., Molina Barcena, V., Montilla Bernabé, A., Villanueva Morán, M.d.P., Blanco Gallego, A.M., Guirao Sánchez, C., Juárez Antón, S., Fernández Rodríguez, Á., Revuelta Puigdollers, M.L., Sarriá Sánchez, M.T., Martín Alegre, C., Martínez Álvarez, M.Á., Mestre de Juan, M., Mielgo Salvador, R., Gijón Seco, M.T., Saníger Herrera, J.M., Rodríguez Jiménez, M.E., Navas de la Peña, B., Santa Cruz Hernández, J., Abad Esteban, A.M., Díaz Martín, R., García Pérez, L., Herrero Vanrell, P., Arias de Saavedra Criado, M.I., Vaquero Vinent, A., López Gómez, V., Montegrifo Rentero, V.M., Simón Miguel, L., Campo Martos, I., Ortiz Zamorano, S., Izquierdo Zamarriego, M.J., Vázquez Carrión, I., López Valero, R.M., Gil, C., Martínez, A. & Soler López, B. (2023). A randomized, double-blind study on the efficacy of oral domperidone versus placebo for reducing SARS-CoV-2 viral load in mild-to-moderate COVID-19 patients in primary health care. Annals of Medicine, 55(2). 10.1080/07853890.2023.2268535
Doi 10.1080/07853890.2023.2268535
Publication Date 17 Oct 2023
Publication Type Article
Researcher Ana Martínez
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