To Evaluate SSD8432/Ritonavir in Adults With COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SSD8432 750mg
* Drug: SSD8432 placebo


Participation Criteria
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Eligibility Criteria
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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-19. 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. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication. Females who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>SSD8432 750mg and Ritonavir 100mg | Drug: SSD8432 750mg<br>* Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID<br>* Other names: Ritonavir 100mg;|
| Placebo Comparator: Control group<br>SSD8432 placebo and Ritonavir placebo | Drug: SSD8432 placebo<br>* Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID<br>* Other names: Ritonavir placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load | Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose) | Baseline through Day6 | 
| Time to Sustained Alleviation | Time to Sustained Alleviation of 5 COVID-19 signs/symptoms | Baseline through Day28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load | Changes of viral load compared to the baseline | Baseline through Day28 | 
| Time to Sustained Alleviation | Time to Sustained Alleviation of target COVID-19 signs/symptoms | Baseline through Day28 | 
| Proportion of participants progress to a worsening status(higher score) | WHO clinical progress scale(0 to 10) | Baseline through Day28 | 
| Adverse events | Frequency of TEAE | Baseline through Day28 | 
| Maximum plasma concentration(Cmax) | Plasma concentration of SSD8432 | Baseline through Day5 |