Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19

NCT05676073 | Completed Phase 2

• 1 other identifier: KXZY-SHEN26-101-Phase-II
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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

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

  Day 7

Secondary Outcomes (11)

• TEAEs and SAEs

  From Baseline up to Day 28

• AEs leading to discontinuation of treatment

  From Baseline up to Day 28

• Drug-related treatment discontinuation

  From Baseline up to Day 28

• New AEs of Grade 3 or higher

  From Baseline up to Day 28

• New drug-related AEs of Grade 3 or higher

  From Baseline up to Day 28

Study Arms (3)

SHEN26 dose 1

EXPERIMENTAL

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

Drug: SHEN26 dose 1

SHEN26 dose 2

EXPERIMENTAL

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

Drug: SHEN26 dose 2

SHEN26 placebo

PLACEBO COMPARATOR

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

Drug: SHEN26 placebo

Interventions

SHEN26 dose 1 DRUG

Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).

SHEN26 dose 1

SHEN26 dose 2 DRUG

Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).

SHEN26 dose 2

SHEN26 placebo DRUG

Placebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).

SHEN26 placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Platelets ≥ 100 × 10\^9 /L.
• Blood creatinine converted endogenous creatinine clearance (Ccr) \> 60 mL/min (according to the Cockcroft-Gault formula).

You may not qualify if:

• 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.
• Subjects with a history of drug or other allergies or who, in the investigator's judgment, may be allergic to the test drug or any component of the test drug.
• Subjects who have undergone major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days prior to dosing or who require elective surgery during the trial period.
• Subjects with a life-threatening illness within 28 days prior to dosing, or other clinically significant illness as judged by the investigator.
• Cardiovascular disease meeting any of the following criteria:
• Prior history of myocardial infarction within 12 months;

Sponsors & Collaborators

• Shenzhen Kexing Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 518112, China

Location

Shenzhen Longhua District People's Hospital

Shenzhen, Guangdong, China

Location

Shijiazhuang Fifth Hospital

Shijiazhuang, Hebei, China

Location

Related Publications (1)

• Bai J, Asakawa T, Yuan W, Lin Y, Ju H, Xu D, Yang M, Li S, Li G, Guo D, Lu H, Zhang X. Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Virol J. 2025 Jan 25;22(1):16. doi: 10.1186/s12985-025-02631-y.

  PMID: 39863888 DERIVED

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Hongzhou Lu, MD, PhD

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 9, 2023
• Study Start: December 8, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 27, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)