Back to resultsTo Evaluate SSD8432/ Ritonavir in Adults With COVID-19
Primary Purpose
COVID-19 Patients
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SSD8432 dose 1/Ritonavir
SSD8432 dose 2/Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Patients
Eligibility Criteria
Inclusion Criteria:
- 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 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.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.
Sites / Locations
- Shenzhen Third People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SSD8432 dose 1
SSD8432 dose 2
Arm Description
SSD8432 dose 1/ritonavir or placebo
SSD8432 dose 2/ritonavir or placebo
Outcomes
Primary Outcome Measures
Adverse events
Frequency of TEAE
Secondary Outcome Measures
Viral load
Changes of viral load compared to the baseline
Time to Sustained Alleviation
Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms
Proportion of Participants Progressing to a Worsening Status (higher score)
WHO clinical progression scale (0 to 10)
Maximum Plasma Concentration [Cmax]
Plasma Concentration of SSD8432
Area Under the Plasma concentration-time Curve [AUC]
Plasma Concentration of SSD8432
Full Information
NCT ID
NCT05369676
First Posted
May 1, 2022
Last Updated
May 29, 2023
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05369676
Brief Title
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
Official Title
Randomized, Double-blind, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetic of SSD8432/ Ritonavir Multiple Doses in Treatment of Adults With Asymptomatic Infection, Mild, and Common Type of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 placebo in asymptomatic, mild, and common type adult COVID-19 subjects.
This clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult COVID-19 subjects, divided into 2 cohorts according to different doses of SSD8432:
Cohort 1: 16 subjects, 12 subjects will receive low-dose SSD8432/ ritonavir, and 4 subjects received placebo; Cohort 2: 16 subjects, 12 subjects will receive high-dose SSD8432/ ritonavir, and 4 subjects received placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSD8432 dose 1
Arm Type
Experimental
Arm Description
SSD8432 dose 1/ritonavir or placebo
Arm Title
SSD8432 dose 2
Arm Type
Experimental
Arm Description
SSD8432 dose 2/ritonavir or placebo
Intervention Type
Drug
Intervention Name(s)
SSD8432 dose 1/Ritonavir
Other Intervention Name(s)
SIM0417 dose 1/Ritonavir
Intervention Description
Cohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；
Intervention Type
Drug
Intervention Name(s)
SSD8432 dose 2/Ritonavir
Other Intervention Name(s)
SIM0417 dose 2/Ritonavir
Intervention Description
Cohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；
Primary Outcome Measure Information:
Title
Adverse events
Description
Frequency of TEAE
Time Frame
Baseline through Day 28
Secondary Outcome Measure Information:
Title
Viral load
Description
Changes of viral load compared to the baseline
Time Frame
Baseline through Day 28
Title
Time to Sustained Alleviation
Description
Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms
Time Frame
Baseline through Day 28
Title
Proportion of Participants Progressing to a Worsening Status (higher score)
Description
WHO clinical progression scale (0 to 10)
Time Frame
Baseline through Day 28
Title
Maximum Plasma Concentration [Cmax]
Description
Plasma Concentration of SSD8432
Time Frame
Baseline through Day 5
Title
Area Under the Plasma concentration-time Curve [AUC]
Description
Plasma Concentration of SSD8432
Time Frame
Baseline through Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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.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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yumei Yang
Organizational Affiliation
Jiangsu Xiansheng Pharmaceutical Co., LTD
Official's Role
Study Director
Facility Information:
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518100
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
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