To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

COVID-19 Patients Clinical Trial

Official title:

Randomized, Double-blind, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetic of SSD8432/ Ritonavir Multiple Doses in Treatment of Adults With Asymptomatic Infection, Mild, and Common Type of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369676
• Other study ID #: B02B11101-103
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 12, 2022
• Est. completion date: August 29, 2022

Study information

• Verified date: May 2023
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Patients

Intervention

Drug:
• SSD8432 dose 1/Ritonavir
Cohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5,BID;
• SSD8432 dose 2/Ritonavir
Cohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5,BID;

Locations

Country	Name	City	State
China	Shenzhen Third People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Frequency of TEAE	Baseline through Day 28
Secondary	Viral load	Changes of viral load compared to the baseline	Baseline through Day 28
Secondary	Time to Sustained Alleviation	Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms	Baseline through Day 28
Secondary	Proportion of Participants Progressing to a Worsening Status (higher score)	WHO clinical progression scale (0 to 10)	Baseline through Day 28
Secondary	Maximum Plasma Concentration [Cmax]	Plasma Concentration of SSD8432	Baseline through Day 5
Secondary	Area Under the Plasma concentration-time Curve [AUC]	Plasma Concentration of SSD8432	Baseline through Day 5