COVID-19
Conditions
Keywords
SHEN211 tablets, multicenter phase II clinical study, efficacy, safety and pharmacokinetics
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.
Interventions
DRUGSHEN211 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.
PROCEDUREPlacebo 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
Sponsors
JKT Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
Randomized 2:1 to experimental and placebo arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in SARS-CoV-2 viral load at each time point | Up to day 28 | Change from baseline in SARS-CoV-2 viral load at each time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to response | Up to day 28 | 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 |
| Time to negative | Up to day 28 | Time to Positive Viral Nucleic Acid Test to Negative |
| Percentage of subjects with disappearance of clinical symptoms | Up to day 28 | Percentage of subjects with disappearance of clinical symptoms on Days 1, 3, 5, 7, 10, 14, 21, and 28 |
| Change in COVID-19 symptom score | Up to day 28 | Change in COVID-19 symptom score from baseline to Days 1, 3, 5, 7, 10, 14, 21, and 28 |
| Time of recovery | Up to day 28 | 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 |
| Change from baseline in chest CT scan (optional) | Up to day 28 | Change from Baseline in Chest CT Scan on Days 3, 7, or 10 (Optional) |
| Percentage of Subjects Progressed | Up to day 28 | Percentage of subjects with COVID-19 progression (progression defined as severe/critical COVID-19 or death due to any cause) by Day 28 |
| Percent of Subjects Who Died | Up to day 28 | Percentage of subjects with all-cause mortality by Day 28 |
| Safety Assessment Results | Up to day 28 | Safety assessments (eg, AEs and SAEs) through Day 28 |
| Ct value change from baseline | Up to day 28 | Change from baseline in SARS-CoV-2 Ct values on Days 1, 3, 5, 7, 10, 14, 21 and 28 |
Countries
China
Contacts
Primary ContactHongzhou Lu, ph.D
Backup ContactXimin Meng
Outcome results
None listed