Official Title
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
Brief Summary

Randomized, double-blind, placebo-controlled, multicenter phase II clinical study ofSHEN211 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.

Not yet recruiting
COVID-19

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 Name: Test group

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 Name: 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Shenzhen Third People 's Hospital
Shenzhen, Guangdong, China

Investigator: Hongzhou Lu, ph.D
Contact: 0755-61232898
luhongzhou@fudan.edu.cn

Investigator: Hongzhou Lu, ph.D

Contacts

Hongzhou Lu, ph.D
0755-61232898
luhongzhou@fudan.edu.cn

Ximin Meng
0755-61238920
szywjd2015@163.com

JKT Biopharma Co., Ltd.
NCT Number
Keywords
SHEN211 tablets
multicenter phase II clinical study
Efficacy
safety and pharmacokinetics
MeSH Terms
COVID-19