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Evaluation of SSD8432 and Ritonavir in Adult Subjects With COVID-19 Clinical Study | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study

NCT05373446•Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Detailed Description

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. This study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 and ≤80 years old, male or female.
•2. Asymptomatic infection,mild or common type of COVID-19.
•3. Initial positive test of SARS-CoV-2 within 5 days of randomization.
•4. Initial onset of COVID-19 signs/symptoms within 3 days of randomization.

Exclusion Criteria

•1. Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
•2. Prior to current disease episode, any confirmed SARS-CoV-2 infection.
•3. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
•4. Receiving dialysis or have known moderate to severe renal impairment.
•5. Known human immunodeficiency virus (HIV) infection.
•6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
•7. Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
•8. Treatment with antivirals against SARS-CoV-2 within 14 days.
•9. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
•10. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
+2 more criteria

Key Dates

Start Date

May 20, 2022

Primary Completion Date

October 31, 2022

Completion Date

March 31, 2023

Last Updated

May 24, 2022

Enrollment

ESTIMATED participants

Conditions

COVID-19

Interventions

SSD8432 300mg

DRUG

SSD8432 750mg

DRUG

SSD8432Placebo

DRUG

Contacts

Genqiang An

CONTACT

86-13520683611 angenqiang@simcere.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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