Status:
UNKNOWN
To Evaluate SSD8432/Ritonavir in Adults With COVID-19
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 COVI...
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 COVI...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT05373433
Start Date
May 26 2022
End Date
October 31 2023
Last Update
May 24 2022
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