<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Els Tobback</style></author><author><style face="normal" font="default" size="100%">Sophie Degroote</style></author><author><style face="normal" font="default" size="100%">Sabine Buysse</style></author><author><style face="normal" font="default" size="100%">Liesbeth Delesie</style></author><author><style face="normal" font="default" size="100%">Lucas Van Dooren</style></author><author><style face="normal" font="default" size="100%">Sophie Vanherrewege</style></author><author><style face="normal" font="default" size="100%">Cyril Barbezange</style></author><author><style face="normal" font="default" size="100%">Veronik Hutse</style></author><author><style face="normal" font="default" size="100%">Marta Romano</style></author><author><style face="normal" font="default" size="100%">Isabelle Thomas</style></author><author><style face="normal" font="default" size="100%">Padalko, Elizaveta</style></author><author><style face="normal" font="default" size="100%">S. Callens</style></author><author><style face="normal" font="default" size="100%">Marie-Angélique De Scheerder</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial.</style></title><secondary-title><style face="normal" font="default" size="100%">Int J Infect Dis</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">COVID-19</style></keyword><keyword><style  face="normal" font="default" size="100%">Double-Blind Method</style></keyword><keyword><style  face="normal" font="default" size="100%">Esters</style></keyword><keyword><style  face="normal" font="default" size="100%">Guanidines</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">SARS-CoV-2</style></keyword><keyword><style  face="normal" font="default" size="100%">Treatment Outcome</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2022 Sep</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">122</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;OBJECTIVES: &lt;/b&gt;This study aimed to assess the efficacy and safety of 300 mg camostat mesylate three times daily in a fasted state to treat early phase COVID-19 in an ambulatory setting.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;METHODS: &lt;/b&gt;We conducted a phase II randomized controlled trial in symptomatic (maximum 5 days) and asymptomatic patients with confirmed COVID-19 infection. Patients were randomly assigned in a 2:1 ratio to receive either camostat mesylate or a placebo. Outcomes included change in nasopharyngeal viral load, time to clinical improvement, the presence of neutralizing antibodies, and safety.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;RESULTS: &lt;/b&gt;Of 96 participants randomized between November 2020 and June 2021, analyses were performed on the data of 90 participants who completed treatment (N&amp;nbsp;=&amp;nbsp;61 camostat mesylate, N&amp;nbsp;=&amp;nbsp;29 placebo). The estimated mean change in cycle threshold between day 1 and day 5 between the camostat and placebo group was 1.183 (P&amp;nbsp;=&amp;nbsp;0.511). The unadjusted hazard ratio for clinical improvement in the camostat group was 0.965 (95% confidence interval, 0.480-1.942, P&amp;nbsp;=&amp;nbsp;0.921 by Cox regression). The percentage distribution of the 50% neutralizing antibody titer at day 28 visit and frequency of adverse events were similar between the two groups.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;CONCLUSION: &lt;/b&gt;Under this protocol, camostat mesylate was not found to be effective as an antiviral drug against SARS-CoV-2.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;TRIAL REGISTRATION: &lt;/b&gt;ClinicalTrials.gov NCT04625114; November 12, 2020.&lt;/p&gt;
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