COVID-19Phase 2/3NCT05373433
To Evaluate SSD8432/Ritonavir in Adults With COVID-19
A Phase 2/3 study testing SSD8432 750mg in people with COVID-19, run by Jiangsu Simcere Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- SSD8432 750mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2022to 31 Oct 2023
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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.
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- 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
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- SSD8432 750mg, SSD8432 placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSD8432 750mgDrug
Also called Ritonavir 100mg
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
SSD8432 placeboDrug
Also called Ritonavir placebo
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SSD8432 750mg and Ritonavir 100mg Receives: Drug: SSD8432 750mg |
| Control group | Placebo comparator | SSD8432 placebo and Ritonavir placebo Receives: Drug: SSD8432 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)
Measured: Baseline through Day6
Time to Sustained Alleviation
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Measured: Baseline through Day28
Secondary outcomes (5)
Viral load
Changes of viral load compared to the baseline
Measured: Baseline through Day28
Time to Sustained Alleviation
Time to Sustained Alleviation of target COVID-19 signs/symptoms
Measured: Baseline through Day28
Proportion of participants progress to a worsening status(higher score)
WHO clinical progress scale(0 to 10)
Measured: Baseline through Day28
Adverse events
Frequency of TEAE
Measured: Baseline through Day28
Maximum plasma concentration(Cmax)
Plasma concentration of SSD8432
Measured: Baseline through Day5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start26 May 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yumei Yang, Doctor, Study director, Jiangsu Xiansheng Pharmaceutical Co.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373433
- Sponsor's protocol ID
- B02B11101-302
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05373433
- Acronym / sponsor ID
- B02B11101-302
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 May 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 13 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, 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.
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 |
|---|---|---|
| Experimental group | Experimental | Drug: SSD8432 750mgSSD8432 750mg and Ritonavir 100mg |
| Control group | Placebo comparator | Drug: SSD8432 placeboSSD8432 placebo and Ritonavir placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
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 750mgAlso: Ritonavir 100mgExperimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID | Drug | Experimental group |
| SSD8432 placeboAlso: Ritonavir placeboControl group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID | Drug | Control group |
Primary outcome
Viral load
Time frame: Baseline through Day6
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 frame: Baseline through Day28
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
5 secondary outcomes
Viral load
Time frame: Baseline through Day28
Time to Sustained Alleviation
Time frame: Baseline through Day28
Proportion of participants progress to a worsening status(higher score)
Time frame: Baseline through Day28
Adverse events
Time frame: Baseline through Day28
Maximum plasma concentration(Cmax)
Time frame: Baseline through Day5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- 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, Doctor study director
Jiangsu Xiansheng Pharmaceutical Co.,
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SSD8432 750mg in people with COVID-19, run by Jiangsu Simcere Pharmaceutical Co., Ltd..
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 7 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: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Genqiang An (86-13520683611, angenqiang@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load (time frame: Baseline through Day6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.