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

NCT ID: NCT06288893

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-01-01

Brief Summary

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHEN211 Tablets

A total of 20 subjects were randomized to the test group

Group Type: ACTIVE_COMPARATOR

SHEN211 Tablets

Intervention Type: DRUG

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.

Placebo for SHEN211 Tablets

10 subjects randomized to placebo

Group Type: PLACEBO_COMPARATOR

Placebo for SHEN211 Tablets

Intervention Type: PROCEDURE

Placebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Other Intervention Names

Test group; control group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JKT Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongzhou Lu, ph.D

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People 's Hospital

Rui Song

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

Shenzhen Third People 's Hospital

Shenzhen, Guangdong, China

Countries

China

Central Contacts

Hongzhou Lu, ph.D

Role: CONTACT

luhongzhou@fudan.edu.cn

0755-61232898

Ximin Meng

Role: CONTACT

szywjd2015@163.com

0755-61238920

Facility Contacts

Hongzhou Lu, ph.D

Role: primary

luhongzhou@fudan.edu.cn

0755-61232898

Ximin Meng

Role: backup

szywjd2015@163.com

0755-61222333 ext. 16565

Other Identifiers

DEU-2001

Identifier Type: -

Identifier Source: org_study_id