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NCT05373446 | Not yet recruiting | COVID-19


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

Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease

COVID-19

Intervention/treatment

SSD8432 300mg

SSD8432 750mg

SSD8432Placebo

Phase

Phase 2

Detailed 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.

Study Type : Interventional
Estimated Enrollment : 72 participants
Masking: Quadruple
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : March 31, 2023
Arm Intervention/treatment

Experimental: SSD8432 300mg

SSD8432 300mg in combination with ritonavir 100mg

Drug: SSD8432 300mg

Experimental: SSD8432 750mg

SSD8432 750mg in combination with ritonavir 100mg

Drug: SSD8432 750mg

Placebo Comparator: SSD8432 placebo

SSD8432 placebo in combination with ritonavir placebo

Drug: SSD8432Placebo

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.
  • Asymptomatic infection,mild or common type of COVID-19.
  • Initial positive test of SARS-CoV-2 within 5 days of randomization.
  • Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
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.

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

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

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