To Evaluate SSD8432/Ritonavir in Adults With COVID-19

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2023

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.

Interventions

  • Drug: SSD8432 dose
    • Experimental group:SSD8432 dose and Ritonavir, Day1–Day5,BID
  • Drug: SSD8432 placebo
    • Control group :SSD8432 placebo and Ritonavir placebo, Day1–Day5,BID

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • SSD8432 does and Ritonavir
  • Placebo Comparator: Control group
    • SSD8432 does placebo and Ritonavir placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Viral load
    • Time Frame: Baseline through Day28
    • Changes of viral load compared to the baseline
  • Time to Sustained Alleviation
    • Time Frame: Baseline through Day28
    • Time to Sustained Alleviation of target COVID-19 signs/symptoms
  • Proportion of participants progress to a worsening status(higher score)
    • Time Frame: Baseline through Day28
    • WHO clinical progress scale(0 to 10)
  • Adverse events
    • Time Frame: Baseline through Day28
    • Frequency of TEAE
  • Maximum plasma concentration(Cmax)
    • Time Frame: Baseline through Day5
    • Plasma concentration of SSD8432

Participating in This Clinical Trial

Inclusion Criteria

1. ≥18 and ≤80 years old, male or female. 2. Initial positive test of SARS-CoV-2 within 5 days of randomization. 3. mild or common type of COVID-19. 4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization. 5. Fever or 1 respiratory symptom of COVID-19 on random day 6. Subjects without high risk factors 7. Subjects with at least one high-risk factor Exclusion Criteria:

1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required. 2. Prior to current disease episode, any confirmed SARS-CoV-2 infection. 3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis). 4. Receiving dialysis or have known moderate to severe renal impairment. 5. Known human immunodeficiency virus (HIV) infection. 6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization.. 8. Treatment with antivirals against SARS-CoV-2 within 14 days. 9. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance. 10. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days. 11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication. 12. Females who are pregnant or breastfeeding.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu Simcere Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yumei Yang, Doctor, Study Director, Jiangsu Xiansheng Pharmaceutical Co.,
  • Overall Contact(s)
    • Genqiang An, 86-13520683611, angenqiang@simcere.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.