Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study

Overview

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.

Full Title of Study: “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

• 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: October 31, 2022

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.

Interventions

• Drug: SSD8432 dose1
  • SSD8432 dose1 in combination with ritonavir, day1–day5,BID
• Drug: SSD8432 dose2
  • SSD8432 dose2 in combination with ritonavir, day1–day5,BID
• Drug: SSD8432Placebo
  • SSD8432Placebo in combination with ritonavir placebo,day1–day5,BID

Arms, Groups and Cohorts

• Experimental: SSD8432 dose 1
  • SSD8432 dose1 in combination with ritonavir
• Experimental: SSD8432 dose 2
  • SSD8432 dose2 in combination with ritonavir
• Placebo Comparator: SSD8432 dose3
  • SSD8432 placebo in combination with ritonavir placebo

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• viral load
  • Time Frame: Baseline through Day28
  • Changes of viral load compared to the baseline
• adverse events
  • Time Frame: Baseline through Day28
  • Frequency of TEAE
• Time to Sustained Alleviation
  • Time Frame: baseline through Day28
  • Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptioms
• Resting oxygen saturation
  • Time Frame: Day1 and Day5
  • Proportion of subjects with resting oxygen saturation ≥ 95%
• Proportion of participants progressing to a worsening status(higher score)
  • Time Frame: Baseline through Day28
  • WHO clinical progression scale(0 to 10)
• 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. Asymptomatic infection,mild or common type of COVID-19. 3. Initial positive test of SARS-CoV-2 within 5 days of randomization. 4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization. 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