A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHEN26 Capsule in Patients With Mild to Moderate COVID-19

Shenzhen Kexing Pharmaceutical Co., Ltd.4 sites in 1 country91 target enrollmentDecember 8, 2022

ConditionsCOVID-19

InterventionsSHEN26 dose 1 SHEN26 dose 2 SHEN26 placebo

DrugsSHEN26 dose 1 SHEN26 dose 2 SHEN26 placebo

Overview

Phase: Phase 2
Intervention: SHEN26 dose 1
Conditions: COVID-19
Sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.
Enrollment: 91
Locations: 4
Primary Endpoint: SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19.

Detailed Description

Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30 patients in each group.

Registry

clinicaltrials.gov

Start Date

December 8, 2022

End Date

January 27, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fully understand the trial's purpose, nature, methods, and possible adverse effects, volunteer as a subject, and sign the informed consent form.
•Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and pledge to use one or more non-pharmacological contraceptives during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug.
•Age 18-65 years (including boundary values, based on the time of signing the informed consent form) of either sex.
•Positive results for SARS-CoV-2 using RT-PCR (Ct value\< 25) in nasopharyngeal swab samples with the first positive nucleic acid test collected ≤ 5 days from Day 1 administration.
•Patients with a diagnosis of mild or moderate COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9).
•Liver function indicators meet the criteria of：
•Alanine aminotransferase (ALT) ≤ 3 × ULN;
•Aspartate aminotransferase (AST) ≤ 3 × ULN;
•Total bilirubin (TBIL) ≤ 2 × ULN.
•Hemoglobin (Hb) ≥ 90 g/L.

Exclusion Criteria

•Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization.
•Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment.
•Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing.
•Subjects who require mechanical ventilation or are expected to require mechanical ventilation.
•Subjects infected with COVID-19 within 3 months prior to dosing.
•Subjects who have received SARS-CoV-2 monoclonal antibody treatment or prophylaxis within 30 days prior to dosing.
•Subjects who have received COVID-19 convalescent plasma or COVID-19 human immunoglobulin treatment within 30 days prior to dosing.
•Subjects who have received treatment or prophylaxis with antiviral drugs (e.g., Paxlovid, Molnupiravir, Remdesivir, lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine, etc.) within 30 days prior to dosing.
•Subjects who have received systemic or inhaled steroids for COVID-19 treatment within 30 days prior to dosing (except for long-term stable dose treatment with concomitant chronic disease and no dose increase).
•Subjects who are on dialysis.

Arms & Interventions

SHEN26 dose 1

SHEN26 capsule 200mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

Intervention: SHEN26 dose 1

SHEN26 dose 2

SHEN26 capsule 400mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

Intervention: SHEN26 dose 2

SHEN26 placebo

Placebo matching the SHEN26 capsule. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h).

Intervention: SHEN26 placebo

Outcomes

Primary Outcomes

SARS-CoV-2 viral RNA level (RT-PCR) on Day 7

Time Frame: Day 7

Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7

Secondary Outcomes

Drug-related treatment discontinuation(From Baseline up to Day 28)
TEAEs and SAEs(From Baseline up to Day 28)
Time to achieve sustained alleviation of COVID-19 symptoms(From Day 1 up to Day 28)
AEs leading to discontinuation of treatment(From Baseline up to Day 28)
New AEs of Grade 3 or higher(From Baseline up to Day 28)
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints(Day 3, Day 5, Day 7, Day 10, Day 28)
Time to achieve SARS-CoV-2 viral clearance(From Baseline up to Day 28)
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints(Day 3, Day 5, Day 7, Day 10, Day 28)
Plasma concentrations of SHEN26-69-0 on Day 5(Day 5)
New drug-related AEs of Grade 3 or higher(From Baseline up to Day 28)
Time to achieve sustained recovery of COVID-19 symptoms(From Day 1 up to Day 28)