- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05373446
Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study
May 23, 2022 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Genqiang An
- Phone Number: 86-13520683611
- Email: angenqiang@simcere.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SSD8432 300mg
SSD8432 300mg in combination with ritonavir 100mg
|
SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID
Other Names:
|
Experimental: SSD8432 750mg
SSD8432 750mg in combination with ritonavir 100mg
|
SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID
Other Names:
|
Placebo Comparator: SSD8432 placebo
SSD8432 placebo in combination with ritonavir placebo
|
SSD8432Placebo in combination with ritonavir placebo,day1--day5,BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first nucleic acid turning negative
Time Frame: Baseline through Day28
|
The time from the first administration to the first nucleic acid turning negative
|
Baseline through Day28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration(Cmax)
Time Frame: Baseline through Day5
|
Plasma concentration of SSD8432
|
Baseline through Day5
|
viral load
Time Frame: Baseline through Day28
|
Changes of viral load compared to the baseline
|
Baseline through Day28
|
adverse events
Time Frame: Baseline through Day28
|
Frequency of TEAE
|
Baseline through Day28
|
Time to Sustained Alleviation
Time Frame: baseline through Day28
|
Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms
|
baseline through Day28
|
Resting oxygen saturation
Time Frame: Day1 and Day5
|
Proportion of subjects with resting oxygen saturation ≥ 95%
|
Day1 and Day5
|
Proportion of participants progressing to a worsening status(higher score)
Time Frame: Baseline through Day28
|
WHO clinical progression scale(0 to 10)
|
Baseline through Day28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yumei Yang, doctor, Jiangsu Xiansheng Pharmaceutical Co.,
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2022
Primary Completion (Anticipated)
October 31, 2022
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 13, 2022
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
Other Study ID Numbers
- B02B11101-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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