Back to resultsEvaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study
Primary Purpose
COVID-19
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SSD8432 300mg
SSD8432 750mg
SSD8432Placebo
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.
- 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.
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 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SSD8432 300mg
SSD8432 750mg
SSD8432 placebo
Arm Description
SSD8432 300mg in combination with ritonavir 100mg
SSD8432 750mg in combination with ritonavir 100mg
SSD8432 placebo in combination with ritonavir placebo
Outcomes
Primary Outcome Measures
Time to first nucleic acid turning negative
The time from the first administration to the first nucleic acid turning negative
Secondary Outcome Measures
viral load
Changes of viral load compared to the baseline
adverse events
Frequency of TEAE
Time to Sustained Alleviation
Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms
Resting oxygen saturation
Proportion of subjects with resting oxygen saturation ≥ 95%
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
Full Information
NCT ID
NCT05373446
First Posted
May 12, 2022
Last Updated
May 23, 2022
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05373446
Brief Title
Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study
Official Title
Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
March 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 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.
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
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SSD8432 300mg
Arm Type
Experimental
Arm Description
SSD8432 300mg in combination with ritonavir 100mg
Arm Title
SSD8432 750mg
Arm Type
Experimental
Arm Description
SSD8432 750mg in combination with ritonavir 100mg
Arm Title
SSD8432 placebo
Arm Type
Placebo Comparator
Arm Description
SSD8432 placebo in combination with ritonavir placebo
Intervention Type
Drug
Intervention Name(s)
SSD8432 300mg
Other Intervention Name(s)
ritonavir 100mg
Intervention Description
SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID
Intervention Type
Drug
Intervention Name(s)
SSD8432 750mg
Other Intervention Name(s)
ritonavir 100mg
Intervention Description
SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID
Intervention Type
Drug
Intervention Name(s)
SSD8432Placebo
Other Intervention Name(s)
ritonavir placebo
Intervention Description
SSD8432Placebo in combination with ritonavir placebo,day1--day5,BID
Primary Outcome Measure Information:
Title
Time to first nucleic acid turning negative
Description
The time from the first administration to the first nucleic acid turning negative
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
adverse events
Description
Frequency of TEAE
Time Frame
Baseline through Day28
Title
Time to Sustained Alleviation
Description
Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms
Time Frame
baseline through Day28
Title
Resting oxygen saturation
Description
Proportion of subjects with resting oxygen saturation ≥ 95%
Time Frame
Day1 and Day5
Title
Proportion of participants progressing to a worsening status(higher score)
Description
WHO clinical progression scale(0 to 10)
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.
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.
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
Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study
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