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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 1 , Mercedes Navarro Pablos 1 , Nuria Viejo Pinero 2 , María Luz Vila Méndez 2 , Verónica Molina Barcena 2 , Aránzazu Montilla Bernabé 3 , María Del Pilar Villanueva Morán 3 , Ana María Blanco Gallego 3 , Carmen Guirao Sánchez 3 , Salvador Juárez Antón 3 , Ángela Fernández Rodríguez 3 , María Luisa Revuelta Puigdollers 4 , María Teresa Sarriá Sánchez 4 , Carmen Martín Alegre 4 , Miguel Ángel Martínez Álvarez 5 , María Mestre de Juan 5 , Rebeca Mielgo Salvador 1 , María Teresa Gijón Seco 1 , José Manuel Saníger Herrera 6 , María Esther Rodríguez Jiménez 6 , Begoña Navas de la Peña 1 , Javier Santa Cruz Hernández 7 , Ana María Abad Esteban 1 , Rebeca Díaz Martín 1 , Laura García Pérez 1 , Paloma Herrero Vanrell 8 , María Isabel Arias de Saavedra Criado 8 , Alexandra Vaquero Vinent 8 , Verónica López Gómez 8 , Víctor Manuel Montegrifo Rentero 9 , Lucía Simón Miguel 9 , Ignacio Campo Martos 10 , Silvia Ortiz Zamorano 10 , María Jesús Izquierdo Zamarriego 11 , Izíar Vázquez Carrión 7 , Rosa María López Valero 12 , Carmen Gil 13 , Ana Martínez 13 14 , Begoña Soler López 15
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 1 , Mercedes Navarro Pablos 1 , Nuria Viejo Pinero 2 , María Luz Vila Méndez 2 , Verónica Molina Barcena 2 , Aránzazu Montilla Bernabé 3 , María Del Pilar Villanueva Morán 3 , Ana María Blanco Gallego 3 , Carmen Guirao Sánchez 3 , Salvador Juárez Antón 3 , Ángela Fernández Rodríguez 3 , María Luisa Revuelta Puigdollers 4 , María Teresa Sarriá Sánchez 4 , Carmen Martín Alegre 4 , Miguel Ángel Martínez Álvarez 5 , María Mestre de Juan 5 , Rebeca Mielgo Salvador 1 , María Teresa Gijón Seco 1 , José Manuel Saníger Herrera 6 , María Esther Rodríguez Jiménez 6 , Begoña Navas de la Peña 1 , Javier Santa Cruz Hernández 7 , Ana María Abad Esteban 1 , Rebeca Díaz Martín 1 , Laura García Pérez 1 , Paloma Herrero Vanrell 8 , María Isabel Arias de Saavedra Criado 8 , Alexandra Vaquero Vinent 8 , Verónica López Gómez 8 , Víctor Manuel Montegrifo Rentero 9 , Lucía Simón Miguel 9 , Ignacio Campo Martos 10 , Silvia Ortiz Zamorano 10 , María Jesús Izquierdo Zamarriego 11 , Izíar Vázquez Carrión 7 , Rosa María López Valero 12 , Carmen Gil 13 , Ana Martínez 13 14 , Begoña Soler López 15
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.