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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 and ≤75, male or female.
- •Asymptomatic Infection, Mild, or Common Type of COVID-
- •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.
Arms & Interventions
SSD8432 dose 1
SSD8432 dose 1/ritonavir or placebo
Intervention: SSD8432 dose 1/Ritonavir (Drug)
SSD8432 dose 2
SSD8432 dose 2/ritonavir or placebo
Intervention: SSD8432 dose 2/Ritonavir (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: Baseline through Day 28
Frequency of TEAE
Secondary Outcomes
- Viral load(Baseline through Day 28)
- Time to Sustained Alleviation(Baseline through Day 28)
- Maximum Plasma Concentration [Cmax](Baseline through Day 5)
- Area Under the Plasma concentration-time Curve [AUC](Baseline through Day 5)
- Proportion of Participants Progressing to a Worsening Status (higher score)(Baseline through Day 28)