Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05373433 | Not yet recruiting | COVID-19

To Evaluate SSD8432/Ritonavir in Adults With COVID-19
Sponsor:

Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease

COVID-19

Intervention/treatment

SSD8432 750mg

SSD8432 placebo

Phase

Phase 2

Phase 3

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 670 participants
Masking : Quadruple
Primary Purpose : Treatment
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
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : October 31, 2023
Arm Intervention/treatment

Experimental: Experimental group

SSD8432 750mg and Ritonavir 100mg

Drug: SSD8432 750mg

Placebo Comparator: Control group

SSD8432 placebo and Ritonavir placebo

Drug: SSD8432 placebo
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • ≥18 and ≤80 years old, male or female.
  • Initial positive test of SARS-CoV-2 within 5 days of randomization.
  • mild or common type of COVID-19.
  • Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
  • Fever or 1 respiratory symptom of COVID-19 on random day
  • Subjects without high risk factors
  • Subjects with at least one high-risk factor
Exclusion Criteria
  • Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
  • Prior to current disease episode, any confirmed SARS-CoV-2 infection.
  • Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
  • Receiving dialysis or have known moderate to severe renal impairment.
  • Known human immunodeficiency virus (HIV) infection.
  • Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
  • Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
  • Treatment with antivirals against SARS-CoV-2 within 14 days.
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
  • Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
  • Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
  • Females who are pregnant or breastfeeding.
To Evaluate SSD8432/Ritonavir in Adults With COVID-19

Location Details

Please Choose a site

To Evaluate SSD8432/Ritonavir in Adults With COVID-19

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations