tetano
Editor, Senior Moderator
Ann Med
. 2023;55(2):2268535.
doi: 10.1080/07853890.2023.2268535. Epub 2023 Oct 17. 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[SUP] 1 [/SUP], Mercedes Navarro Pablos[SUP] 1 [/SUP], Nuria Viejo Pinero[SUP] 2 [/SUP], María Luz Vila Méndez[SUP] 2 [/SUP], Verónica Molina Barcena[SUP] 2 [/SUP], Aránzazu Montilla Bernabé[SUP] 3 [/SUP], María Del Pilar Villanueva Morán[SUP] 3 [/SUP], Ana María Blanco Gallego[SUP] 3 [/SUP], Carmen Guirao Sánchez[SUP] 3 [/SUP], Salvador Juárez Antón[SUP] 3 [/SUP], Ángela Fernández Rodríguez[SUP] 3 [/SUP], María Luisa Revuelta Puigdollers[SUP] 4 [/SUP], María Teresa Sarriá Sánchez[SUP] 4 [/SUP], Carmen Martín Alegre[SUP] 4 [/SUP], Miguel Ángel Martínez Álvarez[SUP] 5 [/SUP], María Mestre de Juan[SUP] 5 [/SUP], Rebeca Mielgo Salvador[SUP] 1 [/SUP], María Teresa Gijón Seco[SUP] 1 [/SUP], José Manuel Saníger Herrera[SUP] 6 [/SUP], María Esther Rodríguez Jiménez[SUP] 6 [/SUP], Begoña Navas de la Peña[SUP] 1 [/SUP], Javier Santa Cruz Hernández[SUP] 7 [/SUP], Ana María Abad Esteban[SUP] 1 [/SUP], Rebeca Díaz Martín[SUP] 1 [/SUP], Laura García Pérez[SUP] 1 [/SUP], Paloma Herrero Vanrell[SUP] 8 [/SUP], María Isabel Arias de Saavedra Criado[SUP] 8 [/SUP], Alexandra Vaquero Vinent[SUP] 8 [/SUP], Verónica López Gómez[SUP] 8 [/SUP], Víctor Manuel Montegrifo Rentero[SUP] 9 [/SUP], Lucía Simón Miguel[SUP] 9 [/SUP], Ignacio Campo Martos[SUP] 10 [/SUP], Silvia Ortiz Zamorano[SUP] 10 [/SUP], María Jesús Izquierdo Zamarriego[SUP] 11 [/SUP], Izíar Vázquez Carrión[SUP] 7 [/SUP], Rosa María López Valero[SUP] 12 [/SUP], Carmen Gil[SUP] 13 [/SUP], Ana Martínez[SUP] 13 14 [/SUP], Begoña Soler López[SUP] 15 [/SUP]
Affiliations
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 < 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.
Keywords: COVID-19 disease; PCR; SARS-CoV-2 virus; domperidone.
. 2023;55(2):2268535.
doi: 10.1080/07853890.2023.2268535. Epub 2023 Oct 17. 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[SUP] 1 [/SUP], Mercedes Navarro Pablos[SUP] 1 [/SUP], Nuria Viejo Pinero[SUP] 2 [/SUP], María Luz Vila Méndez[SUP] 2 [/SUP], Verónica Molina Barcena[SUP] 2 [/SUP], Aránzazu Montilla Bernabé[SUP] 3 [/SUP], María Del Pilar Villanueva Morán[SUP] 3 [/SUP], Ana María Blanco Gallego[SUP] 3 [/SUP], Carmen Guirao Sánchez[SUP] 3 [/SUP], Salvador Juárez Antón[SUP] 3 [/SUP], Ángela Fernández Rodríguez[SUP] 3 [/SUP], María Luisa Revuelta Puigdollers[SUP] 4 [/SUP], María Teresa Sarriá Sánchez[SUP] 4 [/SUP], Carmen Martín Alegre[SUP] 4 [/SUP], Miguel Ángel Martínez Álvarez[SUP] 5 [/SUP], María Mestre de Juan[SUP] 5 [/SUP], Rebeca Mielgo Salvador[SUP] 1 [/SUP], María Teresa Gijón Seco[SUP] 1 [/SUP], José Manuel Saníger Herrera[SUP] 6 [/SUP], María Esther Rodríguez Jiménez[SUP] 6 [/SUP], Begoña Navas de la Peña[SUP] 1 [/SUP], Javier Santa Cruz Hernández[SUP] 7 [/SUP], Ana María Abad Esteban[SUP] 1 [/SUP], Rebeca Díaz Martín[SUP] 1 [/SUP], Laura García Pérez[SUP] 1 [/SUP], Paloma Herrero Vanrell[SUP] 8 [/SUP], María Isabel Arias de Saavedra Criado[SUP] 8 [/SUP], Alexandra Vaquero Vinent[SUP] 8 [/SUP], Verónica López Gómez[SUP] 8 [/SUP], Víctor Manuel Montegrifo Rentero[SUP] 9 [/SUP], Lucía Simón Miguel[SUP] 9 [/SUP], Ignacio Campo Martos[SUP] 10 [/SUP], Silvia Ortiz Zamorano[SUP] 10 [/SUP], María Jesús Izquierdo Zamarriego[SUP] 11 [/SUP], Izíar Vázquez Carrión[SUP] 7 [/SUP], Rosa María López Valero[SUP] 12 [/SUP], Carmen Gil[SUP] 13 [/SUP], Ana Martínez[SUP] 13 14 [/SUP], Begoña Soler López[SUP] 15 [/SUP]
Affiliations
- PMID: 37847999
- 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-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 < 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.
Keywords: COVID-19 disease; PCR; SARS-CoV-2 virus; domperidone.