TY - JOUR T1 -非住院COVID-19患者口服法莫替丁与安慰剂对照:随机、双盲、data-intense 2期临床试验JF -乔肠道肠道SP - 879 LP - 888 - 10.1136 / gutjnl - 2022 - 326952六世- 71 - 5 AU -布伦南,克里斯蒂娜M盟,Nadella Sandeep盟——赵,香非盟-迪玛,理查德•J AU - Jordan-Martin妮可盟——Demestichas Breanna R盟——Kleeman盟阿萨姆-费雷尔,米利暗盟——冯Gablenz,伊娃卡洛塔非盟- Mourikis尼古拉斯AU -鲁宾,迈克尔•E AU - Adnani Harsha AU -李,Hassal盟——哈,Taehoon AU -普鲁姆Soma AU -施莱歇尔Cheryl B AU - Fox, Sharon S AU - Ryan, Michael G AU - Pili, Christina AU - Goldberg, Gary AU - Crawford, James M AU - Goodwin, Sara AU - Zhang, Xiaoyue AU - Preall, Jonathan B AU - Costa, Ana S H AU - Conigliaro, Joseph AU - Masci, Joseph R AU - Yang, Jie AU - Tuveson, David A AU - Tracey, Kevin J AU - Janowitz,目的评价法莫替丁是否能改善轻中度COVID-19门诊患者的炎症反应和症状恢复。随机、双盲、安慰剂对照、完全远程、2期临床试验(NCT04724720),招募了2021年1月至2021年4月期间来自美国两个中心的确诊COVID-19有症状的未接种疫苗的成人门诊患者。患者自行给予80 mg法莫替丁(n=28)或安慰剂(n=27)口服,每天3次,连续14天。终点为(主要)症状缓解时间或(次要)症状缓解率,以及炎症缓解(探索性)。意向治疗组55例患者(中位年龄35岁(IQR: 20);35名女性(64%);18名非裔美国人(33%);14名西班牙裔(26%),52名(95%)完成了试验,提交了1358份电子症状调查。 Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms.Conclusions Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required.Data are available upon reasonable request. The gene list for assessing type-I interferon response is provided in Table S5. ER -