Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study

Phase 2

• Conditions: COVID-19
• Interventions: Drug: SSD8432 300mg; Drug: SSD8432 750mg; Drug: SSD8432Placebo

• Registration Number: NCT05373446
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

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.

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Study Start: 2022-05-20
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24
• Primary Completion: 2022-10-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSD8432 300mg	SSD8432 300mg	SSD8432 300mg in combination with ritonavir 100mg
SSD8432 750mg	SSD8432 750mg	SSD8432 750mg in combination with ritonavir 100mg
SSD8432 placebo	SSD8432Placebo	SSD8432 placebo in combination with ritonavir placebo

Primary Outcome Measures

Name	Time	Method
Time to first nucleic acid turning negative	Baseline through Day28	The time from the first administration to the first nucleic acid turning negative

Secondary Outcome Measures

Name	Time	Method
Proportion of participants progressing to a worsening status(higher score)	Baseline through Day28	WHO clinical progression scale(0 to 10)
Maximum plasma concentration(Cmax)	Baseline through Day5	Plasma concentration of SSD8432
Time to Sustained Alleviation	baseline through Day28	Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms
viral load	Baseline through Day28	Changes of viral load compared to the baseline
adverse events	Baseline through Day28	Frequency of TEAE
Resting oxygen saturation	Day1 and Day5	Proportion of subjects with resting oxygen saturation ≥ 95%