{"title":"评估托法替尼辅助雷米替韦治疗 COVID-19 重症患者疗效的试点和可行性研究","authors":"Mehrdad Dargahi-Malamir, Mofid Hosseinzadeh, Reza Khedri, Hooshmand Hosseininejad, Babak Behmanesh, Ali Hatami, Seyed Yashar Oskouei, Zahra Mehraban, Wesam Kouti, Mandana Pouladzadeh","doi":"10.26574/maedica.2024.19.2.322","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies.</p><p><strong>Method: </strong>Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo.</p><p><strong>Results: </strong>There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006).</p><p><strong>Conclusion: </strong>Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.</p>","PeriodicalId":74094,"journal":{"name":"Maedica","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11345074/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Pilot and Feasibility Study to Evaluate the Effectiveness of Tofacitinib Add-On Therapy to Remdesivir in Severely Ill COVID-19 Patients.\",\"authors\":\"Mehrdad Dargahi-Malamir, Mofid Hosseinzadeh, Reza Khedri, Hooshmand Hosseininejad, Babak Behmanesh, Ali Hatami, Seyed Yashar Oskouei, Zahra Mehraban, Wesam Kouti, Mandana Pouladzadeh\",\"doi\":\"10.26574/maedica.2024.19.2.322\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies.</p><p><strong>Method: </strong>Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo.</p><p><strong>Results: </strong>There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006).</p><p><strong>Conclusion: </strong>Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.</p>\",\"PeriodicalId\":74094,\"journal\":{\"name\":\"Maedica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11345074/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Maedica\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.26574/maedica.2024.19.2.322\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Maedica","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.26574/maedica.2024.19.2.322","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A Pilot and Feasibility Study to Evaluate the Effectiveness of Tofacitinib Add-On Therapy to Remdesivir in Severely Ill COVID-19 Patients.
Aim: This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies.
Method: Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo.
Results: There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006).
Conclusion: Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.