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
Alejandro Rabanal Basalo, Mercedes Navarro Pablos, Nuria Viejo Pinero, María Luz Vila Méndez, Verónica Molina Barcena, Aránzazu Montilla Bernabé, María Del Pilar Villanueva Morán, Ana María Blanco Gallego, Carmen Guirao Sánchez, Salvador Juárez Antón, Ángela Fernández Rodríguez, María Luisa Revuelta Puigdollers, María Teresa Sarriá Sánchez, Carmen Martín Alegre, Miguel Ángel Martínez Álvarez, María Mestre De Juan, Rebeca Mielgo Salvador, María Teresa Gijón Seco, José Manuel Saníger Herrera, María Esther Rodríguez Jiménez, Begoña Navas De La Peña, Javier Santa Cruz Hernández, Ana María Abad Esteban, Rebeca Díaz Martín, Laura García Pérez, Paloma Herrero Vanrell, María Isabel Arias De Saavedra Criado, Alexandra Vaquero Vinent, Verónica López Gómez, Víctor Manuel Montegrifo Rentero, Lucía Simón Miguel, Ignacio Campo Martos, Silvia Ortiz Zamorano, María Jesús Izquierdo Zamarriego, Izíar Vázquez Carrión, Rosa María López Valero, Carmen Gil, Ana Martínez, Begoña Soler López
Annals of Medicine, doi:10.1080/07853890.2023.2268535
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-tomoderate 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 < 0.001) from baseline to days 4, 7 and 14 of the three genes studied with non-significant differences between domperidone and placebo groups. twenty-three patients (13.3%) experienced adverse events, 14 patients in the domperidone group (16.1%) and 9 patients in the placebo group (10.5%). No patients needed to be hospitalized.
Conclusion: Results do not prove the use of domperidone as antiviral in patients with cOViD-19.
Authors contributions
Disclosure statement a. Martínez and c. Gil are employees of the sponsor agencia estatal consejo superior de investigaciones científicas, M.P. (csic). B. soler lópez was contracted to carry out the design, monitoring, statistical analysis and management of the publications derived from the study. the other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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