COVID-19 PatientsPhase 1/2NCT05369676
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
A Phase 1/2 study testing SSD8432 dose 1/Ritonavir and SSD8432 dose 2/Ritonavir in people with COVID-19 Patients, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Patients
- What is being tested?
- SSD8432 dose 1/Ritonavir and SSD8432 dose 2/Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2022to 29 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19 Patients
- Being tested
- SSD8432 dose 1/Ritonavir, SSD8432 dose 2/Ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSD8432 dose 1/RitonavirDrug
Also called SIM0417 dose 1/Ritonavir
Cohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；
SSD8432 dose 2/RitonavirDrug
Also called SIM0417 dose 2/Ritonavir
Cohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；
| Study group | Role | What they receive |
|---|---|---|
| SSD8432 dose 1 | Experimental | SSD8432 dose 1/ritonavir or placebo Receives: Drug: SSD8432 dose 1/Ritonavir |
| SSD8432 dose 2 | Experimental | SSD8432 dose 2/ritonavir or placebo Receives: Drug: SSD8432 dose 2/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Frequency of TEAE
Measured: Baseline through Day 28
Secondary outcomes (5)
Viral load
Changes of viral load compared to the baseline
Measured: Baseline through Day 28
Time to Sustained Alleviation
Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms
Measured: Baseline through Day 28
Proportion of Participants Progressing to a Worsening Status (higher score)
WHO clinical progression scale (0 to 10)
Measured: Baseline through Day 28
Maximum Plasma Concentration [Cmax]
Plasma Concentration of SSD8432
Measured: Baseline through Day 5
Area Under the Plasma concentration-time Curve [AUC]
Plasma Concentration of SSD8432
Measured: Baseline through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start12 May 2022
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PatientsStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yumei Yang, Study director, Jiangsu Xiansheng Pharmaceutical Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369676
- Sponsor's protocol ID
- B02B11101-103
- Status last verified
- May 2023
- First submitted
- 1 May 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao B-F, Yang Y, Xu S-S, Tang B-H, Chen J, Guo Z-J, Hu H-L, Zhang W, Fu S-M, Zhang X-F, Hao G-X, Yang X-M, Song L-L, Ye P-P, Liu L, Zhu S-W, Zheng Y, Zhao W. Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0061425. doi: 10.1128/aac.00614-25. Epub 2025 Sep 18.
PubMed 40965470Wang F, Xiao W, Tang Y, Cao M, Shu D, Asakawa T, Xu Y, Jiang X, Zhang L, Wang W, Tang J, Huang Y, Yang Y, Yang Y, Tang R, Shen J, Lu H. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial. Lancet Reg Health West Pac. 2023 Jul 11;38:100835. doi: 10.1016/j.lanwpc.2023.100835. eCollection 2023 Sep.
PubMed 37484496
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05369676
- Acronym / sponsor ID
- B02B11101-103
- Conditions
- COVID-19 Patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSD8432 dose 1 | Experimental | Drug: SSD8432 dose 1/RitonavirSSD8432 dose 1/ritonavir or placebo |
| SSD8432 dose 2 | Experimental | Drug: SSD8432 dose 2/RitonavirSSD8432 dose 2/ritonavir or placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSD8432 dose 1/RitonavirAlso: SIM0417 dose 1/RitonavirCohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5，BID； | Drug | SSD8432 dose 1 |
| SSD8432 dose 2/RitonavirAlso: SIM0417 dose 2/RitonavirCohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5，BID； | Drug | SSD8432 dose 2 |
Primary outcome
Adverse events
Time frame: Baseline through Day 28
Frequency of TEAE
5 secondary outcomes
Viral load
Time frame: Baseline through Day 28
Time to Sustained Alleviation
Time frame: Baseline through Day 28
Proportion of Participants Progressing to a Worsening Status (higher score)
Time frame: Baseline through Day 28
Maximum Plasma Concentration [Cmax]
Time frame: Baseline through Day 5
Area Under the Plasma concentration-time Curve [AUC]
Time frame: Baseline through Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 40965470Yao B-F, Yang Y, Xu S-S, Tang B-H, Chen J, Guo Z-J, Hu H-L, Zhang W, Fu S-M, Zhang X-F, Hao G-X, Yang X-M, Song L-L, Ye P-P, Liu L, Zhu S-W, Zheng Y, Zhao W. Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0061425. doi: 10.1128/aac.00614-25. Epub 2025 Sep 18.
- Derived from this study: PubMed 37484496Wang F, Xiao W, Tang Y, Cao M, Shu D, Asakawa T, Xu Y, Jiang X, Zhang L, Wang W, Tang J, Huang Y, Yang Y, Yang Y, Tang R, Shen J, Lu H. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial. Lancet Reg Health West Pac. 2023 Jul 11;38:100835. doi: 10.1016/j.lanwpc.2023.100835. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumei Yang study director
Jiangsu Xiansheng Pharmaceutical Co., LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SSD8432 dose 1/Ritonavir and SSD8432 dose 2/Ritonavir in people with COVID-19 Patients, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Baseline through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.