A Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Study Evaluating the Efficacy and Safety of SSD8432 in Combination With Ritonavir in Adult Subjects With Mild/Common COVID-19
Overview
- Phase
- Phase 2
- Intervention
- SSD8432 750mg
- Conditions
- COVID-19
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Enrollment
- 670
- Primary Endpoint
- Time to Sustained Alleviation
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19.
Detailed Description
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19. This study plan to enroll 670 mild or common type adult COVID-19 subjects, Randomly assigned to the experimental group and the control group according to 1:1, experimental group:335subjects will receive SSD8432 and Ritonavir; control group :335subjects will receive SSD8432 placebo and Ritonavir placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥18 and ≤80 years old, male or female.
- •Initial positive test of SARS-CoV-2 within 5 days of randomization.
- •mild or common type of COVID-
- •Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
- •Fever or 1 respiratory symptom of COVID-19 on random day
- •Subjects without high risk factors
- •Subjects with at least one high-risk factor
Exclusion Criteria
- •Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
- •Prior to current disease episode, any confirmed SARS-CoV-2 infection.
- •Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
- •Receiving dialysis or have known moderate to severe renal impairment.
- •Known human immunodeficiency virus (HIV) infection.
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
- •Treatment with antivirals against SARS-CoV-2 within 14 days.
- •Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
- •Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
Arms & Interventions
Experimental group
SSD8432 750mg and Ritonavir 100mg
Intervention: SSD8432 750mg
Control group
SSD8432 placebo and Ritonavir placebo
Intervention: SSD8432 placebo
Outcomes
Primary Outcomes
Time to Sustained Alleviation
Time Frame: Baseline through Day28
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Viral load
Time Frame: Baseline through Day6
Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)
Secondary Outcomes
- Viral load(Baseline through Day28)
- Time to Sustained Alleviation(Baseline through Day28)
- Proportion of participants progress to a worsening status(higher score)(Baseline through Day28)
- Adverse events(Baseline through Day28)
- Maximum plasma concentration(Cmax)(Baseline through Day5)