• 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, and Begoña Soler López.
• C.S. Los Yébenes, Madrid, Spain.
• Ann. Med. 2023 Jan 1; 55 (2): 22685352268535.

IntroductionThe 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 MethodsThe 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.ResultsA 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.ConclusionResults do not prove the use of domperidone as antiviral in patients with COVID-19.

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