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¹Ì±¹±¹¸³º¸°Ç¿ø(NIH ): COVID-19 Ç÷ÀåÄ¡·á RCT Àӻ󿬱¸ ÁøÇà 

(NIH expands clinical trials to test convalescent plasma against COVID-19)

 

 

 

¹Ì±¹±¹¸³º¸°Ç¿ø(National Institute of Health, NIH)Àº COVID-19 Ç÷ÀåÄ¡·á¿¡ ´ëÇÑ ´ë±Ô¸ð ¹«ÀÛÀ§ À§¾à ´ëÁ¶±º ÀÓ»ó½ÃÇ迬±¸(randomized, placebo-controlled clinical trials, RCT)°¡ (National Institutes of Health) ¿¬±¸(NIH expands clinical trials to test convalescent plasma against COVID-19)¸¦ ÁøÇà Áß¿¡ ÀÖ´Ù. COVID-19·Î ÀÔ¿øÇÑ È¯ÀÚ¸¦ À§ÇÑ Ä¡·á¹ýÀ¸·Î ȸº¹±â Ç÷ÀåÄ¡·á È¿°ú¸¦ º¸´Ù È®½ÇÇÏ°í ÀÚ¼¼È÷ °ËÁõÇϱâ À§ÇØ ´ë±Ô¸ð ¹«ÀÛÀ§ÀÓ»ó½ÃÇ迬±¸ 2°ÇÀ» ÁøÇàÇÏ°í ÀÖÀ¸¸ç ÇöÀç ½ÇÇèÀÚ µî·ÏÀ» ¹Ì±¹ ÀüÁÖ·Î È®´ë ÁøÇàÇÏ°í ÀÖ´Ù.

 

9¿ù ÃֽŠ¿¬±¸º¸°í Nature Medicine µî¿¡ µû¸£¸é ȸº¹±â Ç÷ÀåÀº COVID-19¿¡ °É¸° Áߺ´ ¹× ÀÔ¿ø ȯÀÚÀÇ °á°ú¸¦ °³¼± ÇÒ ¼ö ÀÖÀ½À» º¸°íÇß´Ù. ±×·¯³ª ȸº¹±â Ç÷ÀåÀÌ ½ÇÁ¦·Î COVID-19 Ä¡·áÈ¿°ú¿Í ¾ÈÀü¼º °ËÁõÀ» À§Çؼ­´Â ÃæºÐÇÑ µ¥ÀÌÅ͸¦ È®º¸Çؼ­ Æò°¡ÇØ¾ß ÇÑ´Ù. ÀÌ·± ÃëÁö¿¡¼­ NIH´Â ¾ö°ÝÇÏ°Ô ¼³°èµÈ ´ë±Ô¸ð ¹«ÀÛÀ§ ÀÓ»ó½ÃÇ迬±¸¸¦ ÁøÇà Áß¿¡ ÀÖ´Ù.

 


 

±×¸² 1. Donor antibody levels and convalescent plasma-recipient outcomes (From: Nature medicine, September, 2020. Convalescent plasma treatment of severe COVID-19: a propensity score–matched control study, )


 

ȸº¹±â Ç÷ÀåÀº COVID-19¿¡¼­ ȸº¹µÈ »ç¶÷µé·ÎºÎÅÍ Ã¤ÃëÇÑ Ç÷ÀåÀÌ´Ù. ¿©±â¿¡´Â COVID-19 ¿øÀÎÀÌ µÇ´Â ¹ÙÀÌ·¯½º  SARS-CoV-2¿Í ¸é¿ª¹ÝÀÀ¿¡ ±â¿©ÇÒ ¼öÀÖ´Â ±âŸ ±¸¼º¿ä¼Ò¸¦ ÀνÄÇÏ°í ÁßÈ­ ÇÒ ¼öÀÖ´Â Ç×ü°¡ Æ÷ÇԵǾî ÀÖ´Ù.

 

“ÁßÁõ COVID-19 »ç·Ê¿¡ ´ëÇÑ Ä¡·á·Î¼­ ȸº¹±â Ç÷Àå¿¡ ´ëÇÑ ±Ù°Å´Â Èñ¸ÁÀûÀ̱â´Â ÇÏÁö¸¸ ¾ÆÁ÷Àº  ºÒ¿ÏÀüÇÏ´Ù. ÀÌ Ä¡·á¹ýÀÌ ¾î¶»°Ô °á°ú¸¦ °³¼± ÇÒ ¼ö ÀÖ´ÂÁö °áÁ¤Çϱâ À§ÇØ Àß ¼³°èµÈ ¹«ÀÛÀ§ ´ëÁ¶±º ÀÓ»ó½ÃÇ迬±¸¸¦ ¼öÇàÇØ¾ß ÇÑ´Ù.”¶ó°í NIH Ã¥ÀÓÀÚ ÀÎ Francis S. Collins, M.D., Ph.D. ´Â °­Á¶Çß´Ù. "¼¼°è°¡ È¿°úÀûÀÎ ¹é½ÅÀ» ±â´Ù¸®´Â µ¿¾È, ÇöÀç COVID-19·Î ÀÎÇØ ÃÖ¾ÇÀÇ ÇÇÇØ·Î °íÅë¹Þ´Â »ç¶÷µéÀ» À§ÇØ ÀÌ¿ë °¡´ÉÇÑ Ä¡·á ¿É¼ÇÀ» µ¿½Ã¿¡ È®ÀåÇÏ´Â °ÍÀÌ ÇÊ¿äÇÔ."  µµ ¾ð±ÞÇß´Ù. 

 

À̹ø RCT ÀÓ»ó½ÃÇè ¿¬±¸´Â  ´ë±Ô¸ð·Î ¼öÇàµÇ¸ç ³ª¶ó ÀüüÀÇ ÇмúÀû ¹× Áö¿ª»çȸ ±â¹Ý º´¿ø¿¡ ÀÔ¿øÇÑ È¯ÀÚ¸¦  ¸ðµÎ µî·ÏÇÏ¿© ÁøÇàÇÒ °ÍÀ¸·Î °èȹÇÏ°í ÀÖ´Ù. ¿¬±¸ Âü°¡ÀÚ´Â Ä¡·á ¶Ç´Â À§¾àÀ» ¹Þµµ·Ï ¹«ÀÛÀ§·Î ¹èÁ¤µÈ´Ù. °á°ú´Â Àΰø È£Èí±â¿Í °°Àº ÀÓ»ó¼± Á¶Ä¡ ¹× ÀÚ¿ø ¿ä±¸¿Í °ü·ÃÇÏ¿© ºñ±³µÉ °ÍÀÌ°í. µÎ°¡Áö ÀÓ»ó½ÃÇè ¸ðµÎ ÇöÀç Âü°¡ÀÚ¸¦ µî·ÏÇÏ°í ÀÖÀ¸¸ç ºü¸£¸é ¿Ã °¡À»¿¡ °á°ú ¹ßÇ¥¸¦ ¿¹»óÇÏ°í ÀÖ´Ù.

 

À̹ø ÀÓ»ó½ÃÇ迬±¸´Â COVID?19 ¹é½Å, Ä¡·áÁ¦ ¹× Áø´ÜÀÇ °³¹ß, Á¦Á¶ ¹× ¹èÆ÷¸¦ ¹ßÀü½ÃÅ°±â À§ÇØ ¿¬¹æÀÇ °øµ¿ À̴ϼÅƼºêÀÎ OWS (Operation Warp Speed)¸¦ ÅëÇØ 4,800¸¸ ´Þ·¯ Áö¿øÀ» ¹Þ°í ¼öÇàµÇ°í ÀÖ´Ù.

 

NIHÀÇ ÀϺÎÀÎ National Center for Advancing Translational Sciences (NCATS)´Â ÀÓ»ó ¹× Áß°³ °úÇÐ (CTSA) ÇÁ·Î±×·¥ ¿¬±¸ ³×Æ®¿öÅ©¸¦ ÅëÇØ ¿¬±¸ºñ¸¦ Áö¿ø °¨µ¶ÇÑ´Ù. CTSAÀÇ TIN (Trial Innovation Network)Àº COVID-19·Î ÀÎÇØ ºÒ±ÕÇüÇÏ°Ô ¿µÇâÀ»¹Þ´Â Áö¿ª »çȸÀÇ »ç¶÷µéÀ» Æ÷ÇÔÇÏ¿© ¿¬±¸ »çÀÌÆ®¸¦ Ãß°¡ÇÏ°í ȯÀÚ¸¦ µî·ÏÇÏ´Â µ¥ Áß¿äÇÑ ¿ªÇÒÀ» ÇÒ °ÍÀÌ´Ù.



 

NCATS  Ã¥ÀÓÀÚÀÎ Christopher P. Austin “À̹ø¿¡ ¼öÇàµÇ´Â  Áß¿äÇÑ ¹«ÀÛÀ§ÀÓ»ó½ÃÇ迬±¸´Â ȸº¹±â Ç÷Àå ÀÓ»óÄ¡·áÀÇ ±Þ¼ÓÇÑ È®ÀåÀ¸·Î CTSA ÇÁ·Î±×·¥ Çãºê ¹× TIN ³×Æ®¿öÅ©°¡ ±¹°¡ÀÇ ¿¬±¸ ¿ä±¸¿¡ ¾ó¸¶³ª ¹ÎøÇÏ°Ô ´ëÀÀÇÏ°í ¹ß°ß¿¡¼­ Ä¡·á±îÁöÀÇ °æ·Î¸¦ ´ÜÃà ÇÒ ¼ö ÀÖ´ÂÁö º¸¿©ÁÙ ¼ö ÀÖÀ½À» ±â´ëÇÑ´Ù°í ¹àÇû´Ù. 

 

NCATS ¿¬±¸ºñ¸¦ Áö¿ø¹Þ¾Æ ¼öÇàµÇ°í ÀÖ´Â Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients¶ó´Â ÇÑ ÀÓ»ó ½ÃÇèÀº 4 ¿ù ´º¿åÀÇ NYU Langone Health°¡ Albert Einstein College of Medicine ¹× Yale University, New Haven, ConnecticutÀÇ Çù·ÂÀ» ¹Þ¾Æ ½ÃÀ۵Ǿú´Ù. NCATS. ÀÓ»ó½ÃÇ迬±¸ µî·ÏÀ» ´Ã¸®±â À§ÇØ NYU´Â ÈÞ½ºÅÏ¿¡ÀÖ´Â Åػ罺´ëÇÐ º¸°Ç °úÇм¾ÅÍ ¹× Ç÷θ®´Ù¿¡ÀÖ´Â ¸¶ÀÌ¾Ö¹Ì ´ëÇаú Çù·ÂÇÏ¿© À̵é ÁÖ¿¡ÀÖ´Â Âü°¡ÀÚ¸¦ µî·ÏÇÏ¿´´Ù.

 

ÀÌ·¯ÇÑ Ãß°¡ »çÀÌÆ®¸¦ ÅëÇØ À̹ø ½ÃÇèÀº COVID-19 È£Èí±â Áõ»óÀÌÀÖ´Â 18 ¼¼ ÀÌ»óÀÇ ÀÔ¿ø ȯÀÚ ¾à 1,000 ¸íÀ» µî·Ï ÇÒ °ÍÀ¸·Î ¿¹»óµÈ´Ù. À̹ø ÀÓ»ó ½ÃÇèÀº 14ÀÏ°ú 28ÀÏ¿¡ ÀÓ»ó °³¼±À» Æò°¡ÇÏ°í ÀÖÀ¸¸ç »ç¸Á·ü, ÁßȯÀÚ ½Ç ÀÔ¿ø ¹× ȯÀÚ Ç×ü ³óµµ¸¦ ±â¹ÝÀ¸·Î °á°ú¸¦ Æò°¡ÇÒ °ÍÀÌ´Ù. ÀÌ ¿¬±¸ ¹× Âü¿©¿¡ ´ëÇÑ Ãß°¡ Á¤º¸´Â ClinicalTrials.gov¿¡¼­ ¿¬±¸ ½Äº°ÀÚ NCT04364737·Î È®ÀÎÇÒ ¼ö ÀÖ´Ù.

 

COVID-19¿¡ ´ëÇÑ  ¼öµ¿¸é¿ª½ÃÇèµµ ¾à 1,000 ¸íÀÇ Âü°¡ÀÚ¸¦ µî·ÏÇϵµ·Ï È®´ëµÇ°í ÀÖ´Ù. 4 ¿ù¿¡ ½ÃÇèÀ» ½ÃÀÛÇÑ Å׳׽à ÁÖ ³»½´ºô¿¡ÀÖ´Â Vanderbilt University Medical Center´Â CTSA ÇÁ·Î±×·¥ Àü¹Ý¿¡ °ÉÃÄ ¾à 50 °³ÀÇ Ãß°¡ ÀÓ»ó ½ÃÇè »çÀÌÆ®¸¦ ÀÌ¿ëÇÒ ¼ö ÀÖ´Ù. Âü°¡ÀÚ´Â ±Þ¼º È£Èí±â °¨¿° Áõ»ó ¹× ½ÇÇè½Ç¿¡¼­ È®ÀÎ µÈ SARS-CoV-2 °¨¿°ÀÌÀÖ´Â 18 ¼¼ ÀÌ»óÀÌ´Ù. ´ë»óÀÚ´Â ÀÔ¿øÇϰųª ÀÀ±Þ½Ç¿¡ ÀÔ¿ø ÇÒ °¡´É¼ºÀÌ ÀÖÀ¸¸ç, ÁÖ·Î 15ÀÏ¿¡ ÀÓ»óÈ¿°ú¸¦ Æò°¡ÇÏ°í ÀΰøÈ£Èí»ç¿ë, »ê¼Òº¸Ãæ »ç¿ë, ±Þ¼º ½ÅÀå¼Õ»ó ¹× ½ÉÇ÷°ü Áúȯµµ Æò°¡ÇÑ´Ù. ÀÌ ¿¬±¸ ¹× Âü¿©¿¡ ´ëÇÑ Ãß°¡ Á¤º¸´Â ClinicalTrials.gov¿¡¼­ ¿¬±¸ ½Äº°ÀÚ NCT04362176À¸·Î È®ÀÎÇÒ ¼ö ÀÖ´Ù.

 

NCATS (National Center for Advancing Translational Sciences) Á¤º¸ : NCATS´Â ´õ ¸¹Àº ȯÀÚ¿¡°Ô ´õ ¸¹Àº Ä¡·á¸¦ ´õ »¡¸® Á¦°ø ÇÒ ¼ö ÀÖµµ·Ï °Ç°­À» °³¼±ÇϱâÀ§ÇÑ °³ÀÔÀ» °³¹ßÇÏ°í ±¸ÇöÇÏ´Â °úÁ¤À¸·Î Áß°³ °úÇÐ ¹× ¿î¿µ¿¡ ´ëÇÑ ¿¬±¸¸¦ ¼öÇàÇÏ°í Áö¿øÇÑ´Ù. NCATS°¡ °úÇÐÀû ÀÓ»ó °³ÀÔÀ¸·Î COVID-19 ¿µÇâÀ» ´ÜÃàÇÏ´Â ´Ù¾çÇÑ ¿¬±¸´Â https://ncats.nih.gov¸¦ Âü°íÇÏ¿© È®ÀÎÇÒ ¼ö ÀÖ´Ù.






 

Ãâó

Convalescent plasma treatment of severe COVID-19: a propensity score–matched control study (September, 2020). Nature medicine

NIH expands clinical trials to test convalescent plasma against COVID-19 (September, 2020) National Institute of Health







 

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