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

NCT05373446 | Unknown Phase 2

• 1 other identifier: B02B11101-201
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to first nucleic acid turning negative

  The time from the first administration to the first nucleic acid turning negative

  Baseline through Day28

Secondary Outcomes (6)

• viral load

  Baseline through Day28

• adverse events

  Baseline through Day28

• Time to Sustained Alleviation

  baseline through Day28

• Resting oxygen saturation

  Day1 and Day5

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

  Baseline through Day28

Study Arms (3)

SSD8432 300mg

EXPERIMENTAL

SSD8432 300mg in combination with ritonavir 100mg

Drug: SSD8432 300mg

SSD8432 750mg

EXPERIMENTAL

SSD8432 750mg in combination with ritonavir 100mg

Drug: SSD8432 750mg

SSD8432 placebo

PLACEBO COMPARATOR

SSD8432 placebo in combination with ritonavir placebo

Drug: SSD8432Placebo

Interventions

SSD8432 300mg DRUG

SSD8432 300mg in combination with ritonavir 100mg, day1--day5,BID

Also known as: ritonavir 100mg

SSD8432 300mg

SSD8432 750mg DRUG

SSD8432 750mg in combination with ritonavir 100mg, day1--day5,BID

Also known as: ritonavir 100mg

SSD8432 750mg

SSD8432Placebo DRUG

SSD8432Placebo in combination with ritonavir placebo,day1--day5,BID

Also known as: ritonavir placebo

SSD8432 placebo

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.
• 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.

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 20, 2022
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share