To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

Phase 1

Completed

• Conditions: COVID-19 Patients
• Interventions: Drug: SSD8432 dose 1/Ritonavir; Drug: SSD8432 dose 2/Ritonavir

• Registration Number: NCT05369676
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.

Detailed Description

This is a randomized, double-blinded, placebo-controlled, dose-climbing Phase Ib clinical trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of SSD8432/ ritonavir versus placebo in asymptomatic, mild, and common type adult COVID-19 subjects.

This clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult COVID-19 subjects, divided into 2 cohorts according to different doses of SSD8432:

Cohort 1: 16 subjects, 12 subjects will receive low-dose SSD8432/ ritonavir, and 4 subjects received placebo; Cohort 2: 16 subjects, 12 subjects will receive high-dose SSD8432/ ritonavir, and 4 subjects received placebo.

Study Timeline

• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-11
• Study Start: 2022-05-12
• Primary Completion: 2022-08-29
• Study Completion: 2022-08-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age ≥18 and ≤75, 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.
5. The Ct value of SARS-COV-2 nucleic acid test before randomization is ≤ 25, or the Ct value is >25 and sarS-COV-2 serum IgG and IgM are negative.

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.s.
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 dose 1	SSD8432 dose 1/Ritonavir	SSD8432 dose 1/ritonavir or placebo
SSD8432 dose 2	SSD8432 dose 2/Ritonavir	SSD8432 dose 2/ritonavir or placebo

Primary Outcome Measures

Name	Time	Method
Adverse events	Baseline through Day 28	Frequency of TEAE

Secondary Outcome Measures

Name	Time	Method
Viral load	Baseline through Day 28	Changes of viral load compared to the baseline
Time to Sustained Alleviation	Baseline through Day 28	Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms
Maximum Plasma Concentration [Cmax]	Baseline through Day 5	Plasma Concentration of SSD8432
Area Under the Plasma concentration-time Curve [AUC]	Baseline through Day 5	Plasma Concentration of SSD8432
Proportion of Participants Progressing to a Worsening Status (higher score)	Baseline through Day 28	WHO clinical progression scale (0 to 10)

Trial Locations

Locations (1)

Shenzhen Third People's Hospital; 🇨🇳 Shenzhen, Guangdong, China