This study is a multi-center, single-arm, open-label, pilot clinical trial to explore efficacy and safety of Pyramax in mild to moderate COVID-19 patients
This study is a multi-center, single-arm, open-label, pilot clinical trial to explore the efficacy and safety of Pyramax Tab. in patients diagnosed with mild to moderate Coronavirus Disease-19 (COVID-19). Major inclusion criteria are eligible patients confirmed with mild or moderate COVID-19, along with one or more symptoms in association with COVID-19 within 5 days (120 hours) before the screening, who do not need adjunctive oxygen therapy. Subjects eligible to participate in this study will be enrolled and will take Investigational Product once a day for 3 days. Subjects will participate in this study for 29 days in total, and subjects will follow the procedure in accordance with the Schedule of Clinical Trial Events to evaluate efficacy and safety after administration of Investigational Product. Even though subjects are released from quarantine or discharged after showing clinical improvements, subjects should continue to visit hospitals for follow-up until 29 days in accordance with scheduled visit. The criteria of specific discharge (release from quarantine) for confirmed COVID-19 patients with symptoms should follow the latest version of the infectious disease prevention and control guideline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participant body weight * ≥65 kg (Pyramax 4 tablets) * ≥45 kg and \<65 kg (Pyramax 3 tablets)
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, South Korea
Time to negative conversion of COVID-19 infectious viable virus after administration of the investigational product
Time took for subjects with positive infectious viable virus from virus culture at the baseline to get first negative infectious virus test result
Time frame: follow up to Day29
Change from baseline in SARS-CoV-2 infectious virus titer by viral culture
Changes in COVID-19 infectious viral titer compared to the baseline
Time frame: follow up to Day14
Change from baseline in SARS-CoV-2 RNA load by quantitative RT-PCR
Changes in COVID-19 viral RNA load compared to the baseline
Time frame: follow up to Day14
Percentage of subjects requiring acute treatment for more than 24 hours in a hospital or acute treatment facility due to COVID-19 or who have died until 29 days after administration
Proportion of participants with progression to severe COVID-19 through Day 29 assessed by the composite outcome of COVID-19-related adjudicated hospitalization or oxygen therapy or more extensive care or death from any cause
Time frame: follow up to Day29
Percentage of patients with new and aggravated pneumonia until 29 days after administration of the investigational product
Defined as new occurrence or aggravation of existing pneumonia
Time frame: follow up to Day29
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