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RecruitingNCT05908071Updated Jun 22, 2023

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

A Phase 3 interventional study of SHEN26 capsule and SHEN26 placebo in COVID-19, sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants ≥18 years of age, male or female.
  2. The subjects were classified as mild or moderate COVID-19, confirmed SARS-CoV-2 infection 72 hours prior to randomization.
  3. Initial onset 2 of 11 COVID-19 symptoms within 72 hours before randomization, respiratory and feverish symptoms must be included.
  4. Female subjects of childbearing age must have a negative urine pregnancy test during the screening.Fertile participants must agree to take effective contraceptive measures.
  5. Understand the procedures and methods of this clinical trial, after fully informed and they participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Known hypersensitivity to any ingredient in the experimental drug.
  2. Patients with severe or critical COVID-19.
  3. With abnormal liver function observed at the time of screening: total bilirubin ≥ 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.
  4. Subjects with liver diseases, including but not limited to the following diseases, which may affect the safety or efficacy evaluation of subjects during the trial as assessed by the investigator:primary biliary cirrhosis、Child-Pugh Class B or C、acute liver failure.
  5. Subjects with known human immunodeficiency virus (HIV) infection.
  6. Abnormal renal function observed at the time of screening: serum creatinine ≥ 1.5×ULN;or patients receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis at the time of screening.
  7. Subjects with acute exacerbation of chronic respiratory diseases.
  8. Suspected or confirmed acute systemic infections other than COVID-19 observed at the time of screening.
  9. Complications requiring surgery before randomized trial or during the entire trial period and major surgery operated 14 days before the randomized trial,or life-threatening comorbidities considered by the investigator within 30 days before the randomized trial.
  10. Cardiovascular diseases meeting any of the following criteria:History of myocardial infarction within the past 12 months、Unstable angina、Clinically significant and uncontrollable cardiac arrhythmias、History of stroke or transient ischemic attack requiring drug treatment in the past 12 months、Congestive heart failure of grade ≥ II assessed by New York Heart Association (NYHA)、Localized edema of grade ≥3、Clinically uncontrolled hypertension.
  11. Received SARS-CoV-2 monoclonal antibody treatment or prevention within 30 days before the randomized trial.
  12. Received convalescent COVID-19 patient plasma or COVID-19 human immunoglobulin therapy within 30 days before the randomized trial.
  13. Have taken antiviral drugs within 30 days before the randomized trial.
  14. Have taken any COVID-19 vaccine within 3 months or have been infected with new coronavirus within 3 months before the randomized trial.
  15. Pregnant and lactating women.
  16. Have participated in other clinical trials or are using experimental drugs within 3 months before the randomized trial.
  17. Under other conditions that are not suitable for participating in this trial assessed by the investigator.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    SHEN26

    Participants will receive SHEN26 400mg twice daily for 5 days.

    Drug: SHEN26 capsule

  • Placebo comparator
    SHEN26 placebo

    Participants will receive SHEN26 placebo twice daily for 5 days.

    Drug: SHEN26 placebo

Interventions

  • DrugSHEN26 capsule

    Capsule administered orally after meals.

  • DrugSHEN26 placebo

    Capsule administered orally after meals.

06

What researchers measure

Primary outcomes

  1. Time to 11 COVID-19 Symptom Resolution by Day 28

    The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days

    Time frame: Day 1 up to 28

Secondary outcomes

  1. Change of viral load compared to the baseline

    Time frame: Baseline, Day 3, and Day 5

  2. Time to 5 COVID-19 Symptom Resolution by Day 28

    The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days

    Time frame: Day 1 up to 28

  3. Change of viral load compared to the baseline

    Time frame: Baseline, Day 7

  4. Proportion of participants who are negative for SARS-CoV-2 nucleic acid test

    Time frame: baseline, Day 3, Day 5, and Day 7

  5. Time to sustained alleviation of 11 COVID-19 symptoms

    The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days

    Time frame: Day 1 up to 28

  6. Proportion of Participants with COVID-19 related Hospitalization

    Time frame: Day 1 up to 28

  7. Proportion of severe or critical Participants

    Time frame: Day 1 up to 28

  8. Proportion of Participants with All-cause Death

    Time frame: Day 1 up to 28

  9. AE

    Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to 28

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital Of Guangzhou Medical University
    Guangzhou, Guangdong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05908071
Lead sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
May 13, 2023
Primary completion
May 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Jun 22, 2023

Study contacts

Dandan Xu
Contact
xudandan@kexing.com
+8618038100512

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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