E tusa ai ma le fuafuaga, o le a tuʻuina atu e GoldenBiotech le lipoti mulimuli o suʻesuʻega faʻataʻitaʻiga faʻataʻitaʻiga ma faʻamatalaga R&D faʻatatau i le US FDA e talosaga mo faʻalavelave faʻafuaseʻi faʻatagaina (EUA) mo Antroquinonol (HOCENA®).
Ole su'esu'ega lea ole Vaega 2 ole su'esu'ega fa'afuase'i, fa'alua-tauaso, su'esu'ega placebo e iloilo ai le saogalemu ma le aoga ole Antroquinonol ile falema'i ma'i mama'i ma feololo ona ole COVID-19 (Coronavirus SARS-CoV-2 fa'ama'i). O le mea moni, o le faʻataʻitaʻiga na aofia ai foʻi maʻi ogaoga ICU e manaʻomia le lagolago o le okesene. A mae'a uma su'esu'ega su'esu'ega ma fa'amalieina tulaga agava'a, o le a maua e tagata mama'i le 100mg o le Antroquinonol po'o le placebo fa'alua taimi i le aso mo le 14 aso fa'atasi ma le Tulaga o Tausiga (SoC) togafitiga i faiga fa'alotoifale SoC. O le faamasinoga ua maeʻa le faʻafaigaluegaina mo 124 tagata gasegase i Amerika, Peru ma Atenitina lea o loʻo faʻateleina ai le faʻalavelave faʻafuaseʻi ma faʻamaʻi pipisi SARS-CoV-2.
O faʻamatalaga faʻataʻitaʻiga a le falemaʻi na faʻaalia:
1. Fua Fa'atatau Tulaga Muamua: toe fa'aleleia fua [Taimi Taimi: 14 aso]O le aofa'i o tagata mama'i o lo'o ola ma leai se manava fa'aletonu (fa'ata'ita'iga, e leai se mana'oga mo le fa'aosoina o masini, fa'amalo e le fa'asalaina, maualuga le okesene, po'o le ECMO) i luga. Aso 14. Taunuuga: I le vaega Antroquinonol, o le toe faʻaleleia o le 97.9% i le aso 14 asiasiga. E le gata i lea, e leai se maliu poʻo se faʻalavelave manava na maua i le vaega Antroquinonol i le aso 28 asiasiga ma le toe faʻaleleia o le 100%.
2. Fua Faatatau Lua:(a) Umi ole ICU Nofo: I'uga: Ole umi ole umi ole ICU ile vaega ole Antroquinonol e 9.5 aso e pupuu nai lo ile vaega placebo. (b) Le umi o le falemaʻi [ Taimi Taimi: 28 aso]: taimi mo le faʻamalolo o le maʻi. Taunuʻuga: O le umi ole taimi ole falemaʻi o le 4 aso i le vaega o le Antroquinonol.(c) Taimi i le 2-point faʻaleleia [ Taimi Taimi: 28 aso] : Sikoa suiga ile falema'i e pei ona fuaina e le "WHO COVID-19 Clinical Improvement Ordinal Scale".I'uga: O le averesi taimi e togi ai le 0 i le "WHO COVID-19 Clinical Improvement Ordinal Scale" sa 29 aso i le vaega antroquinonol.(d) Taimi e kilia ai virological [ Taimi Taimi: 28 aso]: fuaina e pei o aso su'esu'e mai le amataga o togafitiga e o'o i le su'ega muamua o le SARS-CoV-2 PCR le lelei. I'uga: O le taimi fa'agata i le kilia virological e 14 aso i le vaega Antroquinonol.
I le suʻesuʻeina o le saogalemu, o faʻamaumauga na faʻaalia ai o le Antroquinonol na faʻaalia lelei le faʻamalieina ma le saogalemu.
OA MEA E AVEA MAI LENEI TUSI:
- Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive 100mg of Antroquinonol or placebo two times a day for 14 days in combination with Standard of Care (SoC) therapy per local SoC policies.
- This trial is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Antroquinonol in hospitalized patients with mild to moderate pneumonia due to COVID-19 (Coronavirus SARS-CoV-2 disease).
- Furthermore, no death or respiratory failure was found in the Antroquinonol group at the day 28 visit with recovery ratio of 100%.