Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study

Study Overview
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Brief Summary
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This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.

Detailed Description
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This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19. This study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.

Official Title
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Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SSD8432 300mg
* Drug: SSD8432 750mg
* Drug: SSD8432Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 and ≤80 years old, male or female. Asymptomatic infection,mild or common type of COVID-19. Initial positive test of SARS-CoV-2 within 5 days of randomization. Initial onset of COVID-19 signs/symptoms within 3 days of randomization. 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: SSD8432 300mg<br>SSD8432 300mg in combination with ritonavir 100mg | Drug: SSD8432 300mg<br>* SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID<br>* Other names: ritonavir 100mg;|
| Experimental: SSD8432 750mg<br>SSD8432 750mg in combination with ritonavir 100mg | Drug: SSD8432 750mg<br>* SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID<br>* Other names: ritonavir 100mg;|
| Placebo Comparator: SSD8432 placebo<br>SSD8432 placebo in combination with ritonavir placebo | Drug: SSD8432Placebo<br>* SSD8432Placebo in combination with 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 |
| --- | --- | --- |
| Time to first nucleic acid turning negative | The time from the first administration to the first nucleic acid turning negative | 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 | 
| adverse events | Frequency of TEAE | Baseline through Day28 | 
| Time to Sustained Alleviation | Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms | baseline through Day28 | 
| Resting oxygen saturation | Proportion of subjects with resting oxygen saturation ≥ 95% | Day1 and Day5 | 
| Proportion of participants progressing to a worsening status(higher score) | WHO clinical progression scale(0 to 10) | Baseline through Day28 | 
| Maximum plasma concentration(Cmax) | Plasma concentration of SSD8432 | Baseline through Day5 |