ʻO I-Spy COVID Trial for Critically Terminated: ʻAʻohe hopena nui

ʻO IC14 kahi antibody monoclonal chimeric i koho ʻia no ka hoʻokomo ʻana i ka hoʻokolokolo no ka mea ʻo ka huli ʻana i ka CD14 he hoʻolālā kūpono ia e hoʻololi ai i ka pane kūlohelohe kūlohelohe e hoʻoulu ai i ka maʻi koʻikoʻi a me ka pōʻino kino i ka maʻi COVID-19. Ua hoʻopau ʻia ka hoʻāʻo ʻana o IC14 ma ka ʻōlelo a ke Kōmike Monitoring Data (DMC) ma hope o 66 mau kumuhana i randomized i ka lima IC14 a nānā ʻia i ka heluna Intent-to-Treat (ITT). Ua loaʻa i nā poʻe maʻi i hāʻawi ʻia i ka lima IC14 i ka iwi kuamoʻo, me ka dexamethasone a me ka remdesivir, me ka 4 mg/kg o IC14 e ka infusion intravenous i ka lā 1 a me 2 mg/kg i nā lā 2, 3 a me 4.

Ua hoʻohālikelike ʻia nā hopena IC14 i nā kumuhana 76 i hui pū ʻia me ka lima hoʻomalu iwi kuamoʻo. ʻAʻole i hoʻokō ʻia nā pae hoʻonaʻauao puka, akā ua hoʻokō hapa ʻia nā pae hoʻoholo waiwai ʻole. ʻO ka manaʻo hiki i ka IC14 ke hōʻemi i ka manawa i ka hoʻihoʻi ʻana i manaʻo ʻia he 3.4%; ʻO ka nui o ka lima IC14 ma mua o ka lima hoʻokahi e hōʻemi i ka make i manaʻo ʻia he 62%. Ma hope o ka hōʻea ʻana o nā maʻi āpau i nā lā 28 o ka hahai ʻana, ua ʻōlelo ka ʻikepili he haʻahaʻa haʻahaʻa ka hoʻohui ʻana o IC14 i ka backbone therapy i ka hopena i ka manawa o ka hoʻihoʻi ʻana a i ʻole ka make.

Ua hoʻolālā ʻia ka I-SPY COVID Trial e nānā wikiwiki i nā ʻelele e hōʻike ana i ka ʻōlelo hoʻohiki no ka hōʻemi ʻana i ka manawa e hoʻihoʻi ai (i wehewehe ʻia ʻo ka emi ʻana o ka koi oxygen) a i ʻole ka pilikia o ka make i nā maʻi maʻi COVID-19. Hoʻohana ka haʻawina i ke ʻano hoʻolālā hoʻolālā hoʻāʻo aʻoaʻo a QLHC, e kālele ana i ka loiloi like ʻole a maikaʻi o nā mea noiʻi lehulehu. ʻO nā mea hana mua i loiloi ʻia i ka hoʻokolokolo ʻo cenicriviroc, razuprotafib, apremilast, icatibant a me famotidine me celecoxib. Manaʻo ʻia kahi lima ʻoihana noiʻi no ka hoʻopau ʻana ma muli o ka lapuwale inā ʻaʻole lawa ka hoʻomaikaʻi ʻana i ka hoʻihoʻi ʻana a i ʻole ka make. Ma ke ʻano kikoʻī, pili nā lula lapuwale penei:

1. ʻO ka lāʻau lapaʻau ma mua o 90% hiki ke loaʻa ka liʻiliʻi o ka pōʻino no ka pōmaikaʻi i ka manawa o ka hoʻihoʻi ʻana ma lalo o 1.5 ke hoʻohālikelike ʻia me ka mālama maʻamau (Pr(HR <1.5) ≥ 0.9)

2. ʻOi aku ka nui o ka lakene o ka pōʻino no ka make a me ka iwi kuamoʻo (hoʻololi ʻia no ke kūlana pae COVID-19 ma ka papa kuhikuhi) ma mua o ka ʻoi aʻe a i ʻole like me ka 0.5 (Pr(HRmortality > 1) ≥ 0.5).

Ua lawelawe ʻia ʻo IC14 ma 24 mau pūnaewele US. ʻAʻohe pilikia palekana i pili me IC14 i ka hoʻokolokolo.

Ke hoʻomau nei ka noiʻi ʻana i nā ʻelele hou ma o ka I-SPY COVID Trial, me ka hoʻomau ʻana o nā mea noiʻi i ka nānā wikiwiki ʻana i nā lāʻau lapaʻau e ʻike ai i nā lāʻau lapaʻau maikaʻi loa; He mea nui kēia no QLHC a me kona mau hoa. Aia ka I-SPY COVID Trial i kēia manawa he 24 mau pūnaewele a me nā alakaʻi i nā hale mālama pulmonary a me nā koʻikoʻi mai nā wahi a puni o ka ʻāina.

ʻO ka I-SPY COVID Trial kahi hui pū ʻana ma waena o nā lālā o Quantum Leap, nā hoa lapaʻau e like me Implicit Bioscience a me ke aupuni o ʻAmelika Hui Pū ʻIa. Kākoʻo ʻia kēia hana e ka Biomedical Advanced Research and Development Authority (BARDA), kahi ʻāpana o ke keʻena o ke Kakauolelo Kokua no ka Preparedness and Response i loko o ka US Department of Health and Human Services, a me ka Department of Defense Joint Program Executive Office no Kemimi, Biological, Radiological and Nuclear Defence, me ka hui pū me ka Medical, Chemical, Biological, Radiological and Nuclear (CBRN) Defense Consortium (MCDC)—(contract MCDC2014-001). ʻO ka Defence Threat Reduction Agency (DTRA) e hiki ai i ka Department of Defense (DoD), ke Aupuni US, a me nā hoa hana o ka honua ke kūʻē a pale i nā Weapons of Mass Destruction (WMD) a me Emerging Threats.