This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19.
Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30 patients in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Placebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Shenzhen Longhua District People's Hospital
Shenzhen, Guangdong, China
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China
SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Time frame: Day 7
TEAEs and SAEs
The incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs).
Time frame: From Baseline up to Day 28
AEs leading to discontinuation of treatment
The incidence of AEs leading to discontinuation of study treatment.
Time frame: From Baseline up to Day 28
Drug-related treatment discontinuation
The incidence of drug-related study treatment discontinuation.
Time frame: From Baseline up to Day 28
New AEs of Grade 3 or higher
The incidence of new Grade 3 or higher AE (not present at baseline). The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Time frame: From Baseline up to Day 28
New drug-related AEs of Grade 3 or higher
Incidence of new drug-related AEs of Grade 3 or higher. The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Time frame: From Baseline up to Day 28
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR)
Time frame: Day 3, Day 5, Day 7, Day 10, Day 28
Time to achieve SARS-CoV-2 viral clearance
Viral clearance is defined as two consecutive viral nucleic acid assays with Ct values ≥35 for both N and ORF genes by RT-PCR and an interval of ≥24 hours between sampling. The date of achieving clearance is calculated as the date of the first Ct value ≥ 35).
Time frame: From Baseline up to Day 28
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints
The change in percentage of participants achieving SARS-CoV-2 viral clearance.
Time frame: Day 3, Day 5, Day 7, Day 10, Day 28
Plasma concentrations of SHEN26-69-0 on Day 5
Time frame: Day 5
Time to achieve sustained alleviation of COVID-19 symptoms
Time to achieve sustained alleviation of 11 symptoms of COVID-19 after the first dose, with sustained alleviation defined as a related symptom score of 0 to 1 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Time frame: From Day 1 up to Day 28
Time to achieve sustained recovery of COVID-19 symptoms
Time to achieve sustained recovery of 11 symptoms of COVID-19 after the first dose, with sustained recovery defined as a relevant symptom score of 0 and lasting ≥ 48 hours. The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Time frame: From Day 1 up to Day 28