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A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator¡¦s Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19) www.clinicaltrials.gov/ct2/show/NCT04379271 Brief Summary: At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor¡¦s choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood. Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies. ²nºKn¡G ¥Ø«e¡A©|µL§å㪺Covid-19ÃĪ«ªvÀø¤èªk¡C ¦b³o¶µ¬ã¨s¤¤¡A§ÚÌp¹º½Õ¬d¤@ºØ¥s°µIMU-838¡]vidofludimus¶t¡^ªº¹êÅçÃĪ«¬O§_¥i¥H§ïµ½±zªº¯gª¬¡A¨¾¤î´c¤Æ¥H¦Ü©ó»Ýn¶i¦æ¶i¤@¨BªºªvÀø¡A¨Ò¦p³q®ð¡A¨Ã¥B¥i¥H°§C¯f¬r¼Æ¶q¡]°£¤FÂå¥Íªº¿ï¾Ü¤§¥~¡^ ¼Ð·ÇÀøªk¡C §ÚÌÁÙ±N´ú¸ÕIMU-838¬O§_¦³¥ô¦ó°Æ§@¥Î¡A¨Ã´ú¶q±z¦å²G¤¤IMU 838ªº¤ô¥¡C ¹êÅçÃĪ«ªí¥Ü¸ÓÃĪ«©|¥¼¦b±zªº°ê®a/¦a°Ï¾P°â¡C ¨´¤µ¬°¤î¡A¦b¬ã¨s¤¤¤w¸g¦³¤j¬ù600Ó¤H±µ¨ü¤FIMU-838¡]©ÎÃþ¦ü©óIMU-838ªºÃĪ«¡A¨ä¬¡©Ê¦¨¤À»PIMU-838¬Û¦P¡^¡C Study Design Go to sections Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 230 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: double-blind, placebo-controlled, randomized, parallel-group trial Masking: Double (Participant, Investigator) Masking Description: Trial participants, the investigator and all other personnel directly involved in the conduct of the trial will be blinded to treatment assignments. To maintain the blind, IMU-838 and placebo tablets will have identical appearance, shape and color, and will have identical labeling and packaging. To minimize the potential for bias, treatment randomization information will be kept confidential by the responsible personnel and will not be released to investigators, other trial center personnel, or the Sponsor¡¦s designee(s). Primary Purpose: Treatment Official Title: A Prospective, Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator¡¦s Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 Actual Study Start Date ƒÊ : June 11, 2020 Estimated Primary Completion Date ƒÊ : September 2020 Estimated Study Completion Date ƒÊ : October 2020 ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/10/19 ¤W¤È 11:42:56²Ä 19 ½g¦^À³ Immunic¡AInc.«Å¥¬¥¿¦b¶i¦æªºIMU-838¤¤«×COVID-19±wªÌªº2´ÁCALVID-1¸ÕÅ祿¦b¶i¦æªº¤¤´Á¦w¥þ©Ê¤ÀªR©M©Û¸u§ó·sªºµ²ªG µo§G®É¶¡¡G2020¦~9¤ë28¤é ¯Ã¬ù¡A2020¦~9¤ë28¤é¡A¬ü°ê-Immunic¡AInc.¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GIMUX¡^¬O¤@®aÁ{§É¶¥¬qªº¥Íª«»sÃĤ½¥q¡A¥¿¦b¶}µo¤@¨t¦C¿ï¾Ü©Êªº¤fªA§K¬ÌÀøªk¡A¦®¦bªvÀøºC©Êª¢¯g©M¦Û¨§K¬Ì©Ê¯e¯f¡A¤µ¤Ñ«Å¥¬¤Fµ²ªG¤@¶µ°w¹ï¤¤«×«aª¬¯f¬r¯f2019¡]COVID-19¡^ªº±wªÌªº¿ï¾Ü©Ê¤fªADHODH§í»s¾¯IMU-838ªº¤@¶µ¥¿¦b¶i¦æªº¤¤´Á¦w¥þ©Ê¤ÀªRªº¹w¥ýp¹º©M©Û¶Ò§ó·s¡C®Ú¾Ú¥i¥Îªº¦w¥þ¼Æ¾Ú¡A¿W¥ß¼Æ¾ÚºÊ±±©eû·|¡]IDMC¡^±o¥Xµ²½×¡A¸Ó¬ã¨sÀ³Ä~Äò¶i¦æ¡A¦ÓµL»Ý§ó§ï¡C·í¥iÀò±o§ó¦h±wªÌ¼Æ¾Ú®É¡AIDMC±N°õ¦æ²Ä¤G¦¸¦w¥þ¤ÀªR¡C¨´¤µ¬°¤î¡A¤w¦³110¦W±wªÌ°Ñ¥[¤FCALVID-1¸ÕÅç¡A¨Ã¥B¬ã¨s¶i®i¶¶§Q¡C Immunic¡AInc.À²¼Ð¡]PRNewsfoto / Immunic¡AInc.¡^ ¦b¦¹Á{®É¦w¥þ©Ê¤ÀªR¤¤¡A©Ò¦³¥i¥Îªº¬ã¨s¦w¥þ©Êµ²ªG¹ïIDMCªº¦¨û³£¬O¤£ª¾±¡ªº¡A¦Ó¤½¥q¡A¬ã¨s¤Hû©Mµn°Oªº±wªÌ¤´µM¤£ª¾±¡¡A¨Ã¥BImmunic¨S¦³¦@¨É¥ô¦ó¤£ª¾±¡ªº¼Æ¾Ú¡C¦p¬ã¨s¤è®×¤¤©Ò¹w©w¸qªº¨º¼Ë¡A¸Ó¤ÀªR¬O°ò©óCALVID-1¸ÕÅ礤¶È¨Ó¦Û¬Û¹ï¤Ö¼Æ±wªÌªº¼Æ¾Ú¡A¨Ã¥B¨S¦³¶i¦æ¥¿¦¡ªº²Îp¾Ç¤ÀªR¡C¥¦¬J¤£¬O¦®¦b¶i¦æ®{³Òªº¤ÀªR¡A¤]¤£¬O¬°¤Fµû¦ô¥\®Ä¡C¤@¥¹¤ÀªR¤F§¹¾ãªº¼Æ¾Ú¶°¡A¦¹Á{®É¦w¥þ©Ê¤ÀªR©MIDMC±o¥Xªºµ²½×¥i¯àµLªk¤Ï¬M¸Ó¸ÕÅ窺³Ì²×¤ÀªRµ²ªG¡C Immunicº®uÂå¾Ç©xAndreas MuehlerÂå®vªí¥Ü¡G¡§ IDMCªº«Øij¡A§YµL»Ý§ó§ï¡AÄ~Äò¶i¦æ§Ú̪ºCALVID-1¸ÕÅç¡A¬OIMU-838µo®i¬°COVID-19±wªÌªº¼ç¦bªvÀø¿ï¾Üªº¥t¤@Ó«n¨½µ{¸O¡C ¡C ¡§³o¶µ¬ã¨sªº¿³½ì«Ü±j¡A¤w¸g©Û¶Ò¤F110¦W±wªÌ¡C§ÚÌp¹º¦b¤µ¦~±ß¨Ç®ÉÔ³ø§i¹ï©Ò¦³¥i¥Î¥\®Ä¡A¥Íª«¼Ð»xª«©M¯f¬rºw«×¼Æ¾Ú¶i¦æ¹w¥ýp¹ºªº«Dª¼¥Ø¤¤´Á¤ÀªRªºµ²ªG¡A¤@¥¹¤j¬ù200¦W±wªÌ¸g¹LªvÀø«á¡A§Ú̱N¯à°÷µû¦ô¬O§_¦³¥²n±N¸Óµ{§ÇÂX®i¨ìÅçÃҩʪº3´Á¸ÕÅ礤¡C¡¨ CALVID-1¸ÕÅ窺¥Øªº¬O¬ã¨sIMU-838§@¬°COVID-19ªº¤fªAªvÀø¿ï¾Ü¡A¨Ã¤¹³\¨Ï¥ÎIMU-838§@¬°·í«e©M¼ç¦bªº¥¼¨Ó¤j¬y¦æ©Ê«Â¯ÙªºªvÀø¤èªk¡C¹wp¸Ó¸ÕÅç³Ìªì±N¦b¼Ú¬w©M¬ü°êªº10-35Ó¤¤¤ß©Û¶Ò¬ù230¦W±wªÌ¡C±wªÌ±N³QÀH¾÷¤À°t¬°³sÄò14¤Ñ¨C¤Ñ¨â¦¸±µ¨ü22.5 mg IMU-838¡A©Î¨C¤Ñ¨â¦¸±µ¨ü¦w¼¢¾¯¡C¦b¾ãÓ¬ã¨s¹Lµ{¤¤¡AÂùÁu±wªÌ¤]¦³¸ê®æ±µ¨ü¬ã¨sªÌ¿ï¾Üªº¼Ð·ÇÅ@²z¤èªk¡C¤J¿ï¼Ð·Çn¨D¸g¥@¬É½Ã¥Í²Õ´¡]WHO¡^COVID-19ªvÀø¸ÕÅç·§n´£Ä³ªº¤EÃþ§Ç³e¶qªí¹ï¤w½T¶ESARS-CoV-2·P¬V¡A²Å¦XÁ{§Éª¬ªp3¯Å©Î4¯Åªº¦í°|¦¨¤H±wªÌ¶i¦æµû¦ô¡A¦p¤U¥H¤Î¬Y¨Ç¨ä¥LÁ{§É©M¹êÅç«Ç±ø¥ó¡C¥Dn²×ÂI¬O¾ãÓ¬ã¨s´Á¶¡µL³Ð³q®ðªº±wªÌ¤ñ¨Ò¡C¦¸n²×ÂI¥]¬A¦í°|®É¶¡¡A«¯gºÊÅ@¯f©Ð¡]ICU¡^ªvÀø®É¶¡¡A28¤Ñ¥þ¦]¦º¤`²v¡AÁ{§É§ïµ½®É¶¡©M¯f¬r¸ü¶q®É¶¡¹Lµ{¡C¸Ó¬ã¨s¦®¦b¹w¨¾¦í°|ªºCOVID-19±wªÌªºÁ{§É«¤j¨Ãµo¯g¡CŲ©ó³Ìªñ¦~»´±wªÌªº°Ñ»P©M¥þ²y¤j¬y¦æ¶i®iªº°ÊºAÅܤơAImmunic±NÄ~Äò½Õ¾ã²×ÂI©MÁ{§Éµû¦ô¡A¥H´Á¦³±æ¹L´ç¨ìÁ{§É3´Á¸ÕÅç¡C»P¨Ì¿à¯S©w¯f¬rªºÀøªk¬Û¤ñ¡A¹L¥h´XÓ¤ë¨ÓSARS-CoV-2·sÅÜÅ骺¿ò¶Ç¶i¤Æ¹wp¹ïIMU-838µ¥¹v¦V¯f¬r½Æ»s©Ò»Ýªº¤HÃþ±J¥D²ÓM¥NÁªºÀøªk´X¥G¨S¦³¼vÅT¥Ø¼Ð¡C ¦³Ãö¦¹Á{§É¸ÕÅ窺§ó¦h«H®§¡A½Ð³X°Ý¡Gwww.clinicaltrials.gov¡ANCT04379271¡C www.biospace.com/article/releases/immunic-inc-announces-results-from-interim-safety-analysis-and-recruitment-update-from-its-ongoing-phase-2-calvid-1-trial-of-imu-838-in-patients-with-moderate-covid-19/ ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/10/19 ¤W¤È 11:37:46²Ä 18 ½g¦^À³ www.immunic-therapeutics.com/pipeline/ IMMU-838 ¤fªA, DHODH §é¨î¾¯, §Y±N¶i¤J¤T´ÁÁ{§Éªº¾AÀ³¯g,¦p¤U4ºØ 1.RRMS ´_µo½w¸Ñ«¬¦hµo©Êµw¤Æ¯g 2.COVID-19 |
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