التفاصيل البيبلوغرافية
| 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. |
| 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 |
| المصدر: |
Annals of Medicine; 2023, Vol. 55 Issue 2, p1-13, 13p |
| مصطلحات موضوعية: |
SARS-CoV-2, NON-coding RNA, COVID-19, VIRAL load, PRIMARY health care, DOMPERIDONE |
| مستخلص: |
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. 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. 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. Results do not prove the use of domperidone as antiviral in patients with COVID-19. A 28-day double-blind clinical trial was performed to investigate the antiviral effect of domperidone, 30 mg/day for 7 days (n = 87) versus placebo (n = 86) in outpatients with mild-to-moderate COVID-19. The primary efficacy endpoint was the reduction of viral load on day 4 as compared with baseline, estimated as the cycle thresholds to detect ORF1ab, N Protein and S Protein genes by RT-qPCR in saliva samples. The study findings do not prove the use of domperidone as antiviral in patients with COVID-19. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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