To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    32
  • sponsor
    Jiangsu Simcere Pharmaceutical Co., Ltd.
Updated on 27 May 2022

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.

Details
Condition COVID-19 Patients
Treatment SSD8432 dose 1/Ritonavir, SSD8432 dose 2/Ritonavir
Clinical Study IdentifierNCT05369676
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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