Ngokuvumelana nalolu hlelo, i-GoldenBiotech izohambisa umbiko wokugcina wokuhlaziywa kwesilingo somtholampilo kanye nemibhalo ehlobene ye-R&D ku-FDA yase-US ukuze ufake isicelo sokugunyazwa ukusetshenziswa okuphuthumayo (i-EUA) ye-Antroquinonol (HOCENA®).
Lolu cwaningo luwucwaningo lweSigaba 2 olungahleliwe, olungaboni kabili, olulawulwa yi-placebo ukuze kuhlolwe ukuphepha nokusebenza ngempumelelo kwe-Antroquinonol ezigulini ezilaliswe esibhedlela ezinenyumoniya emaphakathi kuya kwephakathi ngenxa ye-COVID-19 (isifo i-Coronavirus SARS-CoV-2). Empeleni, uhlolo luphinde lwafaka iziguli ezinzima zase-ICU ezidinga ukwesekwa komoyampilo. Ngemva kokuphothulwa kwakho konke ukuhlolwa kokuhlolwa kanye nokuhlangana kwenqubo yokufaneleka, iziguli zizothola i-100mg ye-Antroquinonol noma i-placebo kabili ngosuku ngezinsuku eziyi-14 kuhlanganiswe ne-Standard of Care (SoC) yokwelapha ngezinqubomgomo zasendaweni ze-SoC. Icala liqedele ukuqasha iziguli eziyi-124 e-USA, Peru nase-Argentina lapho ubhubhane olusha ludlange khona ngezinhlobonhlobo ezisakazwa kakhulu ze-SARS-CoV-2.
Idatha yesilingo somtholampilo yembula:
1. Isilinganiso Somphumela Esiyinhloko: isilinganiso sokuthola kabusha [Isikhathi Esibekiwe: izinsuku eziyi-14]Inani leziguli eziphilayo nezingenakho ukuphefumula (isb., asikho isidingo sokungena komoya okuhlaselayo, ukungena komoya okungahlanyisi, umoya wokugeleza okuphezulu, noma i-ECMO) Usuku lwe-14. Umphumela: Eqenjini le-Antroquinonol, isilinganiso sokutakula sasingu-97.9% ngosuku lokuvakasha okuyi-14. Ngaphezu kwalokho, akukho kufa noma ukwehluleka ukuphefumula okutholakele eqenjini le-Antroquinonol ngosuku lwama-28 lokuvakasha ngesilinganiso sokululama esingu-100%.
2. Izilinganiso Zomphumela Wesibili:(a) Ubude besikhathi sokuhlala kwe-ICU:Umphumela: Isikhathi esimaphakathi sokuhlala kwe-ICU eqenjini le-Antroquinonol sasimfushane ngezinsuku ezingu-9.5 kunaleso seqembu le-placebo. (b) Ubude besikhathi sokulaliswa esibhedlela [ Uhlaka Lwesikhathi: izinsuku ezingama-28]: isikhathi sokukhishwa kwesiguli.Umphumela: Ubude besikhathi esimaphakathi sokulaliswa esibhedlela kwakuyizinsuku ezi-4 eqenjini le-Antroquinonol.(c) Isikhathi ukuya kokuthuthukiswa kwamaphuzu angu-2 [ Uhlaka Lwesikhathi: izinsuku ezingu-28] : Isikolo soshintsho lomtholampilo njengoba silinganiswa “nge-WHO COVID-19 Clinical Improvement Ordinal Scale”. Umphumela: Isikhathi esimaphakathi sokuthola amaphuzu angu-0 “ku-WHO COVID-19 Clinical Improvement Ordinal Scale” kwakuyizinsuku ezingu-29 eqenjini le-antroquinonol.(d) Isikhathi sokugunyazwa kwegciwane [ Uhlaka Lwesikhathi: izinsuku ezingama-28]: kulinganiswa njengezinsuku zocwaningo kusukela ekuqaleni kokwelashwa kuya ekuhlolweni kokuqala kwe-SARS-CoV-2 PCR okunegethivu.
Ekuhlolweni kokuphepha, idatha yembula ukuthi i-Antroquinonol ibonise ukubekezelelana okuhle nemiphumela yokuphepha.
