Back to resultsTo Evaluate SSD8432/Ritonavir in Adults With COVID-19
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SSD8432 750mg
SSD8432 placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- ≥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 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.
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
SSD8432 750mg and Ritonavir 100mg
SSD8432 placebo and Ritonavir placebo
Outcomes
Primary Outcome Measures
Viral load
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
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Secondary Outcome Measures
Viral load
Changes of viral load compared to the baseline
Time to Sustained Alleviation
Time to Sustained Alleviation of target COVID-19 signs/symptoms
Proportion of participants progress to a worsening status(higher score)
WHO clinical progress scale(0 to 10)
Adverse events
Frequency of TEAE
Maximum plasma concentration(Cmax)
Plasma concentration of SSD8432
Full Information
NCT ID
NCT05373433
First Posted
May 12, 2022
Last Updated
May 17, 2022
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05373433
Brief Title
To Evaluate SSD8432/Ritonavir in Adults With COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Study Evaluating the Efficacy and Safety of SSD8432 in Combination With Ritonavir in Adult Subjects With Mild/Common COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 26, 2022 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
670 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
SSD8432 750mg and Ritonavir 100mg
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
SSD8432 placebo and Ritonavir placebo
Intervention Type
Drug
Intervention Name(s)
SSD8432 750mg
Other Intervention Name(s)
Ritonavir 100mg
Intervention Description
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
Intervention Type
Drug
Intervention Name(s)
SSD8432 placebo
Other Intervention Name(s)
Ritonavir placebo
Intervention Description
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID
Primary Outcome Measure Information:
Title
Viral load
Description
Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)
Time Frame
Baseline through Day6
Title
Time to Sustained Alleviation
Description
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Time Frame
Baseline through Day28
Secondary Outcome Measure Information:
Title
Viral load
Description
Changes of viral load compared to the baseline
Time Frame
Baseline through Day28
Title
Time to Sustained Alleviation
Description
Time to Sustained Alleviation of target COVID-19 signs/symptoms
Time Frame
Baseline through Day28
Title
Proportion of participants progress to a worsening status(higher score)
Description
WHO clinical progress scale(0 to 10)
Time Frame
Baseline through Day28
Title
Adverse events
Description
Frequency of TEAE
Time Frame
Baseline through Day28
Title
Maximum plasma concentration(Cmax)
Description
Plasma concentration of SSD8432
Time Frame
Baseline through Day5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genqiang An
Phone
86-13520683611
Email
angenqiang@simcere.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yumei Yang, Doctor
Organizational Affiliation
Jiangsu Xiansheng Pharmaceutical Co.,
Official's Role
Study Director
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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