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

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 immud...

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Published in:	Annals of medicine (Helsinki) Vol. 55; no. 2; p. 2268535
Main Authors:	Rabanal Basalo, Alejandro, Navarro Pablos, Mercedes, Viejo Pinero, Nuria, Vila Méndez, María Luz, Molina Barcena, Verónica, Montilla Bernabé, Aránzazu, Villanueva Morán, María del Pilar, Blanco Gallego, Ana María, Guirao Sánchez, Carmen, Juárez Antón, Salvador, Fernández Rodríguez, Ángela, Revuelta Puigdollers, María Luisa, Sarriá Sánchez, María Teresa, Martín Alegre, Carmen, Martínez Álvarez, Miguel Ángel, Mestre de Juan, María, Mielgo Salvador, Rebeca, Gijón Seco, María Teresa, Saníger Herrera, José Manuel, Rodríguez Jiménez, María Esther, Navas de la Peña, Begoña, Santa Cruz Hernández, Javier, Abad Esteban, Ana María, Díaz Martín, Rebeca, García Pérez, Laura, Herrero Vanrell, Paloma, Arias de Saavedra Criado, María Isabel, Vaquero Vinent, Alexandra, López Gómez, Verónica, Montegrifo Rentero, Víctor Manuel, Simón Miguel, Lucía, Campo Martos, Ignacio, Ortiz Zamorano, Silvia, Izquierdo Zamarriego, María Jesús, Vázquez Carrión, Izíar, López Valero, Rosa María, Gil, Carmen, Martínez, Ana, Soler López, Begoña
Format:	Journal Article
Language:	English
Published:	Taylor & Francis 12-12-2023 Taylor & Francis Group
Subjects:	COVID-19 disease domperidone Infectious Diseases PCR SARS-CoV-2 virus
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0785-3890 1365-2060
DOI:	10.1080/07853890.2023.2268535