Status:
COMPLETED
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
COVID-19 Patients
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.
Detailed Description
This is a randomized, double-blinded, placebo-controlled, dose-climbing Phase Ib clinical trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of SSD8432/ ritonavir versus pl...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤75, 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.
- The Ct value of SARS-COV-2 nucleic acid test before randomization is ≤ 25, or the Ct value is \>25 and sarS-COV-2 serum IgG and IgM are negative.
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.s.
- 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 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05369676
Start Date
May 12 2022
End Date
August 29 2022
Last Update
May 31 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China, 518100