SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19)

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SHEN211 Tablets in the Treatment of Patients With Mild and Moderate Novel Coronavirus Infection

Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: SHEN211 Tablets; Procedure: Placebo for SHEN211 Tablets

Detailed Description

A total of 30 patients with mild to moderate novel coronavirus infection (COVID-19) were enrolled and randomized in a 2:1 ratio to the experimental and placebo groups, and subjects received 5 days of oral administration of SHEN211 or SHEN211 placebo to assess the effectiveness of SHEN211 tablets in the treatment of mild to moderate COVID-19 patients.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hongzhou Lu, ph.D; Phone Number: 0755-61232898; Email: luhongzhou@fudan.edu.cn
• Study Contact Backup: Name: Ximin Meng; Phone Number: 0755-61238920; Email: szywjd2015@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518112
      • Shenzhen Third People 's Hospital
      • Contact: Hongzhou Lu, ph.D; Phone Number: 0755-61232898; Email: luhongzhou@fudan.edu.cn
      • Contact: Ximin Meng; Phone Number: 16565 0755-61222333; Email: szywjd2015@163.com
      • Principal Investigator: Hongzhou Lu, ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. subjects must be 18 years of age or older at the time of signing the informed consent form;
2. subject has a positive SARS-CoV-2 test result;
3. Subjects have one or more mild and moderate COVID-19 clinical symptoms with a symptom score of ≥ 2 (see Attached Table 2): fever, cough, sore throat or dry throat, nasal congestion or runny nose, fatigue or fatigue, headache, muscle or body pain (or soreness), shortness of breath or dyspnea, nausea, vomiting, diarrhea; Presence of one or more of the following signs/symptoms within 24 hours prior to randomization: fever, cough, sore throat or dry throat, nasal congestion or runny nose, fatigue or fatigue, headache, muscle or body aches (or aches), shortness of breath or dyspnea, nausea, vomiting, diarrhea;
4. subjects need to meet conditions: 1) The first occurrence of COVID-19 symptoms ≤ 3 days from the first administration of investigational product; 2) Samples for the first positive SARS-CoV-2 virus infection assay were ≤ 5 days from the first administration of investigational product; 3) SARS-CoV-2 viral nucleic acid detection Ct value ≤ 30 on the day of the first dose;
5. Subjects (women and men of childbearing age) and their sexual partners are willing to have no fertility plan and voluntarily take effective contraceptive measures and have no sperm donation or egg donation plan from the signing of the informed consent form to 1 month after the last dose of the study drug (see Appendix 6 for the definition and contraceptive measures of women of childbearing age);
6. The subject is able to understand and abide by the procedures and methods of this clinical trial. After full informed consent, the subject voluntarily participates and signs the informed consent form by himself/herself, or has a legal representative who can provide the informed consent form.

Exclusion Criteria:

1. subjects may progress to severe and severe COVID-19 before randomization as judged by the investigator;
2. SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30/minute on sea-level room air;
3. urgent or expected need for nasal high-flow oxygen therapy or noninvasive positive pressure ventilation, invasive mechanical ventilation, or ECMO;
4. known history of active hepatitis (acute or chronic active hepatitis B or C), cirrhosis, or hepatic decompensation (including ascites, variceal bleeding, or hepatic encephalopathy); impaired immune system (including patients who have been treated with immunosuppressive agents for a long time, or patients with progressive or recurrent cancer, or known human immunodeficiency virus infection);
5. Screening ALT or AST > 1.5 times ULN or Cockcroft-Gault defined known current renal impairment as CrCl < 30 mL/min or requiring dialysis (see Appendix 4 for calculation formula);
6. Subjects who have received antiviral drugs (e.g., neltamivir tablets/ritonavir tablets, azvudine tablets, monoprevir capsules, sinotervir tablets/ritonavir tablets, deuterated remidavir hydrobromide tablets, and Chinese herbal medicine/Chinese patent medicine for anti-coronavirus therapy) treatment or prevention within 30 days before randomization;
7. The subject has received SARS-CoV-2 monoclonal antibody therapy or prophylaxis or antiviral therapy (including study treatment) or the subject has received convalescent COVID-19 plasma therapy;
8. the subject has a history of dysphagia or gastrointestinal disease that seriously affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, subtotal gastrectomy, etc.);
9. acute attack of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease;
10. concurrent influenza at screening, which may interfere with the assessment of response to study intervention based on symptoms, signs, laboratory tests, or imaging indicating a high likelihood of bacterial infection;
11. received any COVID-19 vaccine within 3 months before randomization, or infected with novel coronavirus within 3 months before randomization;
12. Complications requiring surgery before randomization or throughout the study period and major surgery 14 days before randomization, or life-threatening complications within 30 days before randomization as considered by the investigator;
13. Use of the following drugs within 14 days before enrollment: strong cytochrome P453A (CYP3A) inhibitors, strong CYP3A inducers, products containing St. John 's wort (Hypericum perforatum);
14. Participated in other clinical trials or taking experimental drugs within 3 months before randomization;
15. known hypersensitivity to any component used in the formulation of the intervention drug;
16. Pregnant and lactating women;
17. Patients who are judged by the investigator to be inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHEN211 Tablets; A total of 20 subjects were randomized to the test group	Drug: SHEN211 Tablets; SHEN211 tablets, participants will receive 330 mg (3 tablets) QD (once a day) on Day 1 and 110 mg (1 tablet) SHEN211 tablets QD orally on Days 2-5.; Other Names: Test group
Placebo Comparator: Placebo for SHEN211 Tablets; 10 subjects randomized to placebo	Procedure: Placebo for SHEN211 Tablets; Placebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in SARS-CoV-2 viral load at each time point	Change from baseline in SARS-CoV-2 viral load at each time point	Up to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of recovery	To assess the time to first sustained recovery of 5/7/11 clinical symptoms (defined as time from first dose to COVID-19 symptom score of 0 and two days) in mild and moderate COVID-19 patients	Up to day 28
Time to response	To assess time to first sustained resolution of 5/7/11 clinical symptoms (defined as time from first dose to COVID-19 symptom score of 0 or 1 and lasting 2 days) in mild and moderate COVID-19 patients	Up to day 28
Time to negative	Time to Positive Viral Nucleic Acid Test to Negative	Up to day 28
Percentage of subjects with disappearance of clinical symptoms	Percentage of subjects with disappearance of clinical symptoms on Days 1, 3, 5, 7, 10, 14, 21, and 28	Up to day 28
Change in COVID-19 symptom score	Change in COVID-19 symptom score from baseline to Days 1, 3, 5, 7, 10, 14, 21, and 28	Up to day 28
Ct value change from baseline	Change from baseline in SARS-CoV-2 Ct values on Days 1, 3, 5, 7, 10, 14, 21 and 28	Up to day 28
Change from baseline in chest CT scan (optional)	Change from Baseline in Chest CT Scan on Days 3, 7, or 10 (Optional)	Up to day 28
Percentage of Subjects Progressed	Percentage of subjects with COVID-19 progression (progression defined as severe/critical COVID-19 or death due to any cause) by Day 28	Up to day 28
Percent of Subjects Who Died	Percentage of subjects with all-cause mortality by Day 28	Up to day 28
Safety Assessment Results	Safety assessments (eg, AEs and SAEs) through Day 28	Up to day 28

Collaborators and Investigators

• Sponsor: JKT Biopharma Co., Ltd.
• Investigators: Principal Investigator: Hongzhou Lu, ph.D, Shenzhen Third People 's Hospital; Principal Investigator: Rui Song, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: efficacy; SHEN211 tablets; multicenter phase II clinical study; safety and pharmacokinetics
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DEU-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No