COVID-19
Conditions
Brief summary
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
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.
Interventions
DRUGSSD8432 300mg
SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID
DRUGSSD8432 750mg
SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID
DRUGSSD8432Placebo
SSD8432Placebo in combination with 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. Asymptomatic infection,mild or common type of COVID-19. 3. Initial positive test of SARS-CoV-2 within 5 days of randomization. 4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
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 |
|---|---|---|
| Time to first nucleic acid turning negative | Baseline through Day28 | The time from the first administration to the first nucleic acid turning negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| viral load | Baseline through Day28 | Changes of viral load compared to the baseline |
| adverse events | Baseline through Day28 | Frequency of TEAE |
| Time to Sustained Alleviation | baseline through Day28 | Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms |
| Resting oxygen saturation | Day1 and Day5 | Proportion of subjects with resting oxygen saturation ≥ 95% |
| Proportion of participants progressing to a worsening status(higher score) | Baseline through Day28 | WHO clinical progression scale(0 to 10) |
| Maximum plasma concentration(Cmax) | Baseline through Day5 | Plasma concentration of SSD8432 |
Contacts
Primary ContactGenqiang An
Outcome results
None listed