A Phase 3 interventional study of SHEN26 capsule and SHEN26 placebo in COVID-19, sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shenzhen Kexing Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive SHEN26 400mg twice daily for 5 days.
Drug: SHEN26 capsule
Participants will receive SHEN26 placebo twice daily for 5 days.
Drug: SHEN26 placebo
Capsule administered orally after meals.
Capsule administered orally after meals.
Time to 11 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
Time frame: Day 1 up to 28
Change of viral load compared to the baseline
Time frame: Baseline, Day 3, and Day 5
Time to 5 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days
Time frame: Day 1 up to 28
Change of viral load compared to the baseline
Time frame: Baseline, Day 7
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time frame: baseline, Day 3, Day 5, and Day 7
Time to sustained alleviation of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days
Time frame: Day 1 up to 28
Proportion of Participants with COVID-19 related Hospitalization
Time frame: Day 1 up to 28
Proportion of severe or critical Participants
Time frame: Day 1 up to 28
Proportion of Participants with All-cause Death
Time frame: Day 1 up to 28
AE
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to 28
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Shenzhen Kexing Pharmaceutical Co., Ltd.