To Evaluate SSD8432/Ritonavir in Adults With COVID-19

NCT05373433 | Unknown Phase 2

• 1 other identifier: B02B11101-302
• Study Type: interventional
• Target: 670
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Viral load

  Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)

  Baseline through Day6

• Time to Sustained Alleviation

  Time to Sustained Alleviation of 5 COVID-19 signs/symptoms

  Baseline through Day28

Secondary Outcomes (5)

• Viral load

  Baseline through Day28

• Time to Sustained Alleviation

  Baseline through Day28

• Proportion of participants progress to a worsening status(higher score)

  Baseline through Day28

• Adverse events

  Baseline through Day28

• Maximum plasma concentration(Cmax)

  Baseline through Day5

Study Arms (2)

Experimental group

EXPERIMENTAL

SSD8432 750mg and Ritonavir 100mg

Drug: SSD8432 750mg

Control group

PLACEBO COMPARATOR

SSD8432 placebo and Ritonavir placebo

Drug: SSD8432 placebo

Interventions

SSD8432 750mg DRUG

Experimental group:SSD8432 750mg and Ritonavir 100mg, Day1--Day5,BID

Also known as: Ritonavir 100mg

Experimental group

SSD8432 placebo DRUG

Control group :SSD8432 placebo and Ritonavir placebo, Day1--Day5,BID

Also known as: Ritonavir placebo

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

COVID-19

Interventions

SIM0417; Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yumei Yang, Doctor

  Jiangsu Xiansheng Pharmaceutical Co.,

  STUDY DIRECTOR

Central Study Contacts

Genqiang An

CONTACT

86-13520683611; angenqiang@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 13, 2022
• Study Start: May 26, 2022
• Primary Completion: May 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share