Study design and objectives
VIRUS, SECONDARY
This was a phase III, randomized, double-blind, parallel group, placebo controlled, multicentre clinical trial conducted in 17 primary healthcare centres located in autonomous community of Madrid, Spain. The study period began on 22 March 2022 and finished on 3 November 2022. Each patient was followed up for 28 days.The primary objective was to assess the efficacy of domperidone versus placebo on reducing viral load at day 4 from baseline. Secondary objectives included evaluating the efficacy of domperidone in achieving negative polymerase chain reaction (PCR) from baseline, to reduce the severity and duration of symptoms, to assess the need of medical care, admission to the hospital and oxygen therapy, and the mortality rate at day 28. All secondary objectives were included in the analysis to explore time and clinical consequences of exposure to viral load as the reduction in viral load is related to a lower frequency in the onset of symptoms, a lower severity of symptoms and a lower likelihood of hospital admission, as well as a reduction in the contagiousness of the virus.The study was conducted in accordance with the last version of the Declaration of Helsinki and approved by the Medicinal Product Research Ethics Committee of Hospital Universitario Puerta de Hierro, Majadahonda (Madrid, Spain; code 1/2022, approval date 25 January 2022). The study was registered at European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) with number 2021-001228-17. All the patients signed a written informed consent.