Kuyesa kwa I-Spy COVID kwa Odwala Kwambiri Kuthetsedwa: Palibe Chochitika Chachikulu

IC14 ndi chimeric monoclonal antibody yomwe idasankhidwa kuti ilowe mumlanduwo chifukwa kulunjika kwa CD14 kungakhale njira yoyenera yosinthira kuyankha kwa chitetezo cham'thupi komwe kumayambitsa matenda oopsa komanso kuwonongeka kwa chiwalo mu matenda a COVID-19. Kuyesedwa kwa IC14 kunathetsedwa malinga ndi malingaliro a Komiti Yoyang'anira Data (DMC) pambuyo pa maphunziro a 66 omwe adasinthidwa ku mkono wa IC14 ndikuwunikidwa mu chiwerengero cha Intent-to-Treat (ITT). Odwala omwe adatumizidwa ku mkono wa IC14 adalandira chithandizo chamsana, kuphatikiza dexamethasone ndi remdesivir, kuphatikiza 4 mg/kg ya IC14 mwa kulowetsedwa m'mitsempha patsiku 1 ndi 2 mg/kg pamasiku 2, 3 ndi 4.

Zotsatira za IC14 zinafaniziridwa ndi maphunziro a 76 omwe adasinthidwa nthawi imodzi ndi mkono wolamulira msana. Zolinga za omaliza maphunziro sizinakwaniritsidwe, koma njira zopanda pake zidakwaniritsidwa pang'ono. Kuthekera kuti IC14 ingachepetse nthawi yobwezeretsa inali yoti ndi 3.4%; mwayi woti mkono wa IC14 ndi wapamwamba kuposa mkono womwewo kuti uchepetse kufa unayesedwa kukhala 62%. Odwala onse atafikira masiku a 28 akutsatiridwa, deta inanena kuti panali mwayi wochepa kuti kuwonjezera kwa IC14 ku chithandizo cha msana kungakhale ndi zotsatira pa nthawi yochira kapena kufa.

Mayesero a I-SPY COVID adapangidwa kuti aziwonetsa mwachangu othandizira omwe amawonetsa lonjezo lochepetsa nthawi yochira (yotanthauzidwa ngati kuchepetsa kufunikira kwa okosijeni) kapena chiwopsezo cha kufa kwa odwala omwe akudwala kwambiri COVID-19. Kafukufukuyu amagwiritsa ntchito njira yoyeserera yoyeserera ya QLHC, yomwe imayang'ana kwambiri kuwunika kwanthawi imodzi, kothandiza kwa othandizira angapo ofufuza. Othandizira am'mbuyomu omwe adayesedwa pachiyeso ndi cenicriviroc, razuprotafib, apremilast, icatibant ndi famotidine kuphatikiza celecoxib. Wothandizira wofufuza akulimbikitsidwa kuti athetsedwe chifukwa chachabechabe ngati palibe kusintha kokwanira pakuchira kapena kufa. Mwachindunji, malamulo otsatirawa opanda pake amagwira ntchito:

1. Mankhwalawa amadutsa mwayi wa 90% kuti chiwopsezo chopindulitsa panthawi yochira ndi chochepa kuposa 1.5 poyerekeza ndi mankhwala ochiritsira (Pr (HR <1.5) ≥ 0.9)

2. Kuthekera kwapambuyo kwa chiwopsezo cha kufa kwa anthu onse motsutsana ndi msana (wosinthidwa kuti ukhale mulingo wa COVID-19 poyambira) ndi wokulirapo kuposa kapena wofanana ndi 0.5 (Pr(HRmortality > 1) ≥ 0.5).

IC14 idayendetsedwa pamasamba 24 omwe akutenga nawo gawo ku US. Panalibe nkhawa zokhudzana ndi chitetezo chokhudzana ndi IC14 pakuyesa.

Kufufuza kwa othandizira owonjezera kudzera mu I-SPY COVID Trial kukupitilira, ndipo ofufuzawo akupitiliza kuyang'ana mwachangu chithandizo chamankhwala kuti adziwe achire omwe ali othandiza kwambiri; Izi zikadali zofunika kwambiri kwa QLHC ndi mabwenzi ake. Mayesero a I-SPY COVID tsopano akuphatikiza masamba 24 komanso atsogoleri m'malo osamalira odwala m'mapapo ndi owopsa ochokera kuzungulira dzikolo.

I-SPY COVID Trial ndi mgwirizano pakati pa mamembala a Quantum Leap, othandizira azachipatala monga Implicit Bioscience ndi boma la United States. Ntchitoyi imathandizidwa ndi gawo lina la Biomedical Advanced Research and Development Authority (BARDA), yomwe ili gawo la ofesi ya Mlembi Wothandizira Wokonzekera ndi Kuyankha mu US Department of Health and Human Services, ndi Ofesi Yoyang'anira Dipatimenti Yoyang'anira Chitetezo ku United States. Chemical, Biological, Radiological and Nuclear Defense, mogwirizana ndi Medical, Chemical, Biological, Radiological and Nuclear (CBRN) Defense Consortium (MCDC)—(contract MCDC2014-001). Defence Threat Reduction Agency (DTRA) imathandizira Dipatimenti ya Chitetezo (DoD), Boma la US, ndi International Partners kulimbana ndi kuletsa Zida Zowononga Misa (WMD) ndi Ziwopsezo Zowopsa.