To Evaluate SSD8432/Ritonavir in Adults With COVID-19

Phase 2

• Conditions: COVID-19
• Interventions: Drug: SSD8432 placebo; Drug: SSD8432 750mg

• Registration Number: NCT05373433
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24
• Study Start: 2022-05-26
• Primary Completion: 2023-05-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 670

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	SSD8432 placebo	SSD8432 placebo and Ritonavir placebo
Experimental group	SSD8432 750mg	SSD8432 750mg and Ritonavir 100mg

Primary Outcome Measures

Name	Time	Method
Time to Sustained Alleviation	Baseline through Day28	Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Viral load	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)

Secondary Outcome Measures

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