I-Spy Gwajin COVID don Ƙarshen Rashin Lafiya: Babu Babban Tasiri

IC14 wani maganin rigakafi ne na monoclonal na chimeric wanda aka zaɓa don haɗawa a cikin gwajin saboda niyya CD14 na iya zama dabarar da ta dace don daidaita martanin rigakafi na gida wanda ke haifar da mummunar cuta da lalata gaɓoɓin gaɓoɓin cutar COVID-19. An dakatar da gwajin IC14 bisa shawarar Kwamitin Kula da Bayanai (DMC) bayan da aka yi amfani da batutuwa na 66 zuwa hannun IC14 kuma an yi nazari a cikin yawan jama'ar Intent-to-Treat (ITT). Marasa lafiya da aka sanya wa hannu na IC14 sun sami maganin kashin baya, ciki har da dexamethasone da remdesivir, da 4 mg/kg na IC14 ta hanyar jiko na jini a rana ta 1 da 2 mg/kg a ranakun 2, 3 da 4.

Sakamakon IC14 an kwatanta shi da batutuwa 76 waɗanda aka bazu a lokaci guda zuwa hannun sarrafa kashin baya. Ba a cika ka'idojin kammala karatun ba, amma an cika ka'idojin rashin amfani da wani bangare. Yiwuwar cewa IC14 na iya rage lokacin dawowa zuwa 3.4%; yuwuwar cewa hannun IC14 ya fi na hannu na lokaci guda don rage mace-mace an kiyasta kashi 62%. Bayan duk marasa lafiya sun kai kwanaki 28 na biyo baya, bayanan sun nuna cewa akwai ƙananan yiwuwar cewa ƙarin IC14 zuwa maganin kashin baya zai yi tasiri a kan lokaci don dawowa ko mace-mace.

An tsara gwajin I-SPY COVID don hanzarta tantance wakilai waɗanda ke nuna alƙawarin rage lokacin murmurewa (wanda aka ayyana azaman raguwar buƙatar iskar oxygen) ko haɗarin mace-mace a cikin marasa lafiya na COVID-19. Binciken yana amfani da hanyar ƙirar ƙirar ƙirar dandamali mai daidaitawa ta QLHC, wanda ke mai da hankali kan lokaci guda, ingantaccen ƙima na wakilai na bincike da yawa. Wakilan da aka tantance a baya sun haɗa da cenicriviroc, razuprotafib, apremilast, icatibant da famotidine da celecoxib. Ana ba da shawarar hannun wakilin bincike don ƙarewa saboda rashin amfani idan babu isasshen ci gaba a farfadowa ko mace-mace. Musamman, dokokin banza masu zuwa suna aiki:

1.          Magani ya ketare yuwuwar kashi 90% na haɗarin fa'ida a lokacin dawowa bai wuce 1.5 ba idan aka kwatanta da daidaitaccen magani (Pr (HR <1.5) ≥ 0.9)

2.          Yiwuwar ƙimar haɗarinsa don yawan mace-mace da kashin baya (wanda aka daidaita don matsayin COVID-19 a tushe) ya fi ɗaya girma ko daidai da 0.5 (Pr (HRmortality> 1) ≥ 0.5).

An gudanar da IC14 a shafukan Amurka 24 masu shiga. Babu wata damuwa ta aminci da ke da alaƙa da IC14 a cikin gwajin.

Ana ci gaba da gudanar da bincike kan ƙarin wakilai ta hanyar gwajin COVID-24 na I-SPY, tare da masu binciken suna ci gaba da bincikar jiyya cikin sauri don gano hanyoyin warkewa masu inganci; wannan ya kasance babban fifiko na gaggawa ga QLHC da abokan aikin sa. Gwajin COVID na I-SPY yanzu ya ƙunshi shafuka XNUMX da kuma shugabanni a cibiyoyin kula da huhu da masu mahimmanci daga ko'ina cikin ƙasar.

Gwajin COVID na I-SPY haɗin gwiwa ne tsakanin membobin Quantum Leap, abokan hulɗar magunguna irin su Implicit Bioscience da gwamnatin Amurka. Wannan aikin yana samun goyan bayan wani ɓangare ta Cibiyar Bincike da Ci gaba ta Biomedical (BARDA), wani ɓangare na ofishin Mataimakin Sakatare don Shiryewa da Amsa a cikin Ma'aikatar Lafiya da Ayyukan Jama'a na Amurka, da Ofishin Gudanarwa na Haɗin gwiwar Ma'aikatar Tsaro don Chemical, Biological, Radiological and Nuclear Defense, tare da haɗin gwiwar Medical, Chemical, Biological, Radiological and Nuclear (CBRN) Defence Consortium (MCDC) - (kwangilar MCDC2014-001). Hukumar Rage Barazana ta Tsaro (DTRA) tana ba wa Ma'aikatar Tsaro (DoD), Gwamnatin Amurka, da Abokan Hulɗa na Duniya damar magancewa da hana Makamai na Rushewar Jama'a (WMD) da Barazana masu tasowa.