To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

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.

Inclusion criteria

• Age ≥18 and ≤75, 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.
• 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

• 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.s.
• 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.