학술논문
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.
Document Type
Academic Journal
Author
Rabanal Basalo A; C.S. Los Yébenes, Madrid, Spain.; Navarro Pablos M; C.S. Los Yébenes, Madrid, Spain.; Viejo Pinero N; C.S. Fronteras, Torrejón de Ardoz, Spain.; Vila Méndez ML; C.S. Fronteras, Torrejón de Ardoz, Spain.; Molina Barcena V; C.S. Fronteras, Torrejón de Ardoz, Spain.; Montilla Bernabé A; C.S. Benita de Ávila, Madrid, Spain.; Villanueva Morán MDP; C.S. Benita de Ávila, Madrid, Spain.; Blanco Gallego AM; C.S. Benita de Ávila, Madrid, Spain.; Guirao Sánchez C; C.S. Benita de Ávila, Madrid, Spain.; Juárez Antón S; C.S. Benita de Ávila, Madrid, Spain.; Fernández Rodríguez Á; C.S. Benita de Ávila, Madrid, Spain.; Revuelta Puigdollers ML; C.S. Baviera, Madrid, Spain.; Sarriá Sánchez MT; C.S. Baviera, Madrid, Spain.; Martín Alegre C; C.S. Baviera, Madrid, Spain.; Martínez Álvarez MÁ; C.S. Los Alperchines, San Fernando de Henares, Spain.; Mestre de Juan M; C.S. Los Alperchines, San Fernando de Henares, Spain.; Mielgo Salvador R; C.S. Los Yébenes, Madrid, Spain.; Gijón Seco MT; C.S. Los Yébenes, Madrid, Spain.; Saníger Herrera JM; C.S. General Fanjul, Madrid, Spain.; Rodríguez Jiménez ME; C.S. General Fanjul, Madrid, Spain.; Navas de la Peña B; C.S. Los Yébenes, Madrid, Spain.; Santa Cruz Hernández J; C.S. Daroca, Madrid, Spain.; Abad Esteban AM; C.S. Los Yébenes, Madrid, Spain.; Díaz Martín R; C.S. Los Yébenes, Madrid, Spain.; García Pérez L; C.S. Los Yébenes, Madrid, Spain.; Herrero Vanrell P; C.S. Reina Victoria, Madrid, Spain.; Arias de Saavedra Criado MI; C.S. Reina Victoria, Madrid, Spain.; Vaquero Vinent A; C.S. Reina Victoria, Madrid, Spain.; López Gómez V; C.S. Reina Victoria, Madrid, Spain.; Montegrifo Rentero VM; Clínica Monmar, Las Rozas, Spain.; Simón Miguel L; Clínica Monmar, Las Rozas, Spain.; Campo Martos I; C.S. Las Rozas El Abajón, Las Rozas, Spain.; Ortiz Zamorano S; C.S. Las Rozas El Abajón, Las Rozas, Spain.; Izquierdo Zamarriego MJ; C.S. Villablanca, Madrid, Spain.; Vázquez Carrión I; C.S. Daroca, Madrid, Spain.; López Valero RM; C.S. Dos de Mayo, Móstoles, Spain.; Gil C; Centro de Investigaciones Biológicas 'Margarita Salas', CSIC, Madrid, Spain.; Martínez A; Centro de Investigaciones Biológicas 'Margarita Salas', CSIC, Madrid, Spain.; Centro de Investigación Biomédica en Red en Enfermedades Neurodegenerativas, ISCiii, Madrid, Spain.; Soler López B; Medical Department, E-C-BIO, S.L., Las Rozas, Spain.
Source
Publisher: Informa Healthcare Country of Publication: England NLM ID: 8906388 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2060 (Electronic) Linking ISSN: 07853890 NLM ISO Abbreviation: Ann Med Subsets: MEDLINE
Subject
Language
English
Abstract
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.
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.