COVID-19
Conditions
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.
Interventions
DRUGSSD8432 750mg
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
DRUGSSD8432 placebo
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 and ≤80 years old, male or female. 2. Initial positive test of SARS-CoV-2 within 5 days of randomization. 3. mild or common type of COVID-19. 4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization. 5. Fever or 1 respiratory symptom of COVID-19 on random day 6. Subjects without high risk factors 7. Subjects with at least one high-risk factor
Exclusion criteria
1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required. 2. Prior to current disease episode, any confirmed SARS-CoV-2 infection. 3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis). 4. Receiving dialysis or have known moderate to severe renal impairment. 5. Known human immunodeficiency virus (HIV) infection. 6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization.. 8. Treatment with antivirals against SARS-CoV-2 within 14 days. 9. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance. 10. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days. 11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication. 12. Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral load | 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) |
| Time to Sustained Alleviation | Baseline through Day28 | Time to Sustained Alleviation of 5 COVID-19 signs/symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sustained Alleviation | Baseline through Day28 | Time to Sustained Alleviation of target COVID-19 signs/symptoms |
| Maximum plasma concentration(Cmax) | Baseline through Day5 | Plasma concentration of SSD8432 |
| Adverse events | Baseline through Day28 | Frequency of TEAE |
| Proportion of participants progress to a worsening status(higher score) | Baseline through Day28 | WHO clinical progress scale(0 to 10) |
| Viral load | Baseline through Day28 | Changes of viral load compared to the baseline |
Contacts
Primary ContactGenqiang An
Outcome results
None listed