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Randomized Controlled Trial
. 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
Randomized Controlled Trial

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 et al. Ann Med. 2023.

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.

Keywords: COVID-19 disease; PCR; SARS-CoV-2 virus; domperidone.

Plain language summary

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.

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Conflict of interest statement

A. Martínez and C. Gil are employees of the sponsor Agencia Estatal Consejo Superior de Investigaciones Científicas, M.P. (CSIC). B. Soler López was contracted to carry out the design, monitoring, statistical analysis and management of the publications derived from the study. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
Flow chart of the study population. Analysis was based on the ITT dataset.
Figure 2.
Figure 2.
Evolution of Ct values of ORF1ab, N Protein and S Protein at follow-up in the two study groups.
Figure 3.
Figure 3.
Kaplan–Meier curves for the median time to obtain an RT-qPCR negative result by study group.
See this image and copyright information in PMC

References

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