To Evaluate SSD8432/Ritonavir in Adults With COVID-19

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: SSD8432 750mg; Drug: SSD8432 placebo

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 Type: Interventional
• Enrollment (Anticipated): 670
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Genqiang An; Phone Number: 86-13520683611; Email: angenqiang@simcere.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; SSD8432 750mg and Ritonavir 100mg	Drug: SSD8432 750mg; Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID; Other Names: Ritonavir 100mg
Placebo Comparator: Control group; SSD8432 placebo and Ritonavir placebo	Drug: SSD8432 placebo; Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID; Other Names: Ritonavir placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load	Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)	Baseline through Day6
Time to Sustained Alleviation	Time to Sustained Alleviation of 5 COVID-19 signs/symptoms	Baseline through Day28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Study Director: Yumei Yang, doctor, Jiangsu Xiansheng Pharmaceutical Co.,

Study record dates

Study Major Dates

• Study Start (Anticipated): May 26, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): October 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 17, 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: B02B11101-302

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