دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | 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, Iziar, López Valero, Rosa María, Gil, Carmen, Martínez Gil, Ana, Soler López, Begoña |
| المساهمون: | Consejo Superior de Investigaciones Científicas (España), European Commission, Rabanal Basalo, Alejandro, Vila Méndez, María Luz, Mielgo Salvador, Rebeca, Abad Esteban, Ana María, Gil, Carmen, Martínez Gil, Ana, Soler López, Begoña |
| بيانات النشر: | Taylor & Francis |
| سنة النشر: | 2023 |
| المجموعة: | Digital.CSIC (Consejo Superior de Investigaciones Científicas / Spanish National Research Council) |
| مصطلحات موضوعية: | SARS-CoV-2 virus, COVID-19 disease, Domperidone, PCR |
| الوصف: | 15 p.-3 fig.-3 tab. ; 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. ; This research was funded by CSIC (grant no. PIE 201980E024) and by the European Commission: NextGeneration EU (Regulation EU 2020/2094) through CSIC’s Global Health Platform (PTI Salud Global). The study sponsor was Agencia Estatal Consejo Superior de Investigaciones Científicas, M.P. (CSIC), Madrid, Spain. The sponsor was involved in the design, data interpretation, manuscript review and the decision to submit the article for publication. ; Peer reviewed |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0785-3890 1365-2060 |
| العلاقة: | Publisher's version; https://doi.org/10.1080/07853890.2023.2268535Test; Sí; Annals of Medicine 55 (2) 2268535 (2023); http://hdl.handle.net/10261/341652Test |
| DOI: | 10.1080/07853890.2023.2268535 |
| الإتاحة: | https://doi.org/10.1080/07853890.2023.2268535Test http://hdl.handle.net/10261/341652Test |
| حقوق: | open |
| رقم الانضمام: | edsbas.8F24E60E |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 07853890 13652060 |
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| DOI: | 10.1080/07853890.2023.2268535 |