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

Simcere

Status and phase: Unknown; Phase 2

Conditions: COVID-19

Treatments: Drug: SSD8432 300mg; Drug: SSD8432Placebo; Drug: SSD8432 750mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05373446

B02B11101-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.
11. Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
12. Females who are pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

SSD8432 300mg

Experimental group

Description:

SSD8432 300mg in combination with ritonavir 100mg

Treatment:

Drug: SSD8432 300mg

SSD8432 750mg

Experimental group

Description:

SSD8432 750mg in combination with ritonavir 100mg

Treatment:

Drug: SSD8432 750mg

SSD8432 placebo

Placebo Comparator group

Description:

SSD8432 placebo in combination with ritonavir placebo

Treatment:

Drug: SSD8432Placebo