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

COVID-19 Clinical Trial

Official title:

Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05373446
• Other study ID #: B02B11101-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 20, 2022
• Est. completion date: March 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 31, 2023
• Est. primary completion date: October 31, 2022
• 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. 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• SSD8432 300mg
SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID
• SSD8432 750mg
SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID
• SSD8432Placebo
SSD8432Placebo in combination with 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	Time to first nucleic acid turning negative	The time from the first administration to the first nucleic acid turning negative	Baseline through Day28
Secondary	viral load	Changes of viral load compared to the baseline	Baseline through Day28
Secondary	adverse events	Frequency of TEAE	Baseline through Day28
Secondary	Time to Sustained Alleviation	Time to Sustained Alleviation of Targeted COVID-19 Signs/symptoms	baseline through Day28
Secondary	Resting oxygen saturation	Proportion of subjects with resting oxygen saturation = 95%	Day1 and Day5
Secondary	Proportion of participants progressing to a worsening status(higher score)	WHO clinical progression scale(0 to 10)	Baseline through Day28
Secondary	Maximum plasma concentration(Cmax)	Plasma concentration of SSD8432	Baseline through Day5