To Evaluate SSD8432/Ritonavir in Adults With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05373433
• Other study ID #: B02B11101-302
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: May 26, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2022
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Genqiang An
• Phone: 86-13520683611
• Email: angenqiang[@]simcere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 670
• Est. completion date: October 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• SSD8432 750mg
Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID
• SSD8432 placebo
Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to Sustained Alleviation	Time to Sustained Alleviation of 5 COVID-19 signs/symptoms	Baseline through Day28
Secondary	Viral load	Changes of viral load compared to the baseline	Baseline through Day28
Secondary	Time to Sustained Alleviation	Time to Sustained Alleviation of target COVID-19 signs/symptoms	Baseline through Day28
Secondary	Proportion of participants progress to a worsening status(higher score)	WHO clinical progress scale(0 to 10)	Baseline through Day28
Secondary	Adverse events	Frequency of TEAE	Baseline through Day28
Secondary	Maximum plasma concentration(Cmax)	Plasma concentration of SSD8432	Baseline through Day5