COVID-19Phase 2NCT06288893
SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19)
A Phase 2 study testing SHEN211 Tablets in people with COVID-19, run by JKT Biopharma Co., Ltd. at 1 site in China.
Trial summary
Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- SHEN211 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects must be 18 years of age or older at the time of signing the informed consent form;
- subject has a positive SARS-CoV-2 test result;
- 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;
- 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;
- 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);
- 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.
Who cannot join
- subjects may progress to severe and severe COVID-19 before randomization as judged by the investigator;
- SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30/minute on sea-level room air;
- urgent or expected need for nasal high-flow oxygen therapy or noninvasive positive pressure ventilation, invasive mechanical ventilation, or ECMO;
- 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);
- 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);
- 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;
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- 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;
- 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.);
- acute attack of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease;
- 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;
- received any COVID-19 vaccine within 3 months before randomization, or infected with novel coronavirus within 3 months before randomization;
- 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;
- 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);
- Participated in other clinical trials or taking experimental drugs within 3 months before randomization;
- known hypersensitivity to any component used in the formulation of the intervention drug;
- Pregnant and lactating women;
- Patients who are judged by the investigator to be inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Third People 's Hospital
Shenzhen, Guangdong, 518112
Hongzhou Lu, ph.D, 0755-61232898, luhongzhou@fudan.edu.cn
Ximin Meng, 0755-61222333 ext. 16565, szywjd2015@163.com
About this study
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
Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets
Read the 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
- Being tested
- SHEN211 Tablets, Placebo for SHEN211 Tablets
- Keywords
- SHEN211 tablets, multicenter phase II clinical study, efficacy, safety and pharmacokinetics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHEN211 TabletsDrug
Also called Test group
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 TabletsProcedure or surgery
Also called control group
Placebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5
| Study group | Role | What they receive |
|---|---|---|
| SHEN211 Tablets | Active comparator | A total of 20 subjects were randomized to the test group Receives: Drug: SHEN211 Tablets |
| Placebo for SHEN211 Tablets | Placebo comparator | 10 subjects randomized to placebo Receives: Procedure: Placebo for SHEN211 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to day 28
Secondary outcomes (10)
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
Measured: 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
Measured: Up to day 28
Time to negative
Time to Positive Viral Nucleic Acid Test to Negative
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Up to day 28
Percent of Subjects Who Died
Percentage of subjects with all-cause mortality by Day 28
Measured: Up to day 28
Safety Assessment Results
Safety assessments (eg, AEs and SAEs) through Day 28
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 2:1 to experimental and placebo arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JKT Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongzhou Lu, ph.D, Principal investigator, Shenzhen Third People 's HospitalRui Song, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288893
- Sponsor's protocol ID
- DEU-2001
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06288893
- Acronym / sponsor ID
- DEU-2001
- Conditions
- COVID-19
- Keywords
- SHEN211 tablets, multicenter phase II clinical study, efficacy, safety and pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- JKT Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 2:1 to experimental and placebo arms
| Arm | Type | Receives |
|---|---|---|
| SHEN211 Tablets | Active comparator | Drug: SHEN211 TabletsA total of 20 subjects were randomized to the test group |
| Placebo for SHEN211 Tablets | Placebo comparator | Procedure: Placebo for SHEN211 Tablets10 subjects randomized to placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects must be 18 years of age or older at the time of signing the informed consent form;
- subject has a positive SARS-CoV-2 test result;
- 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;
- 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;
- 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);
Key exclusion criteria (17 listed)
- subjects may progress to severe and severe COVID-19 before randomization as judged by the investigator;
- SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30/minute on sea-level room air;
- urgent or expected need for nasal high-flow oxygen therapy or noninvasive positive pressure ventilation, invasive mechanical ventilation, or ECMO;
- 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);
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHEN211 TabletsAlso: Test groupSHEN211 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. | Drug | SHEN211 Tablets |
| Placebo for SHEN211 TabletsAlso: control groupPlacebo tablets, participants will receive 3 tablets QD (once daily) on Day 1 and 1 tablet QD orally on Days 2-5 | Procedure or surgery | Placebo for SHEN211 Tablets |
Primary outcome
Change from baseline in SARS-CoV-2 viral load at each time point
Time frame: Up to day 28
Change from baseline in SARS-CoV-2 viral load at each time point
10 secondary outcomes
Time of recovery
Time frame: Up to day 28
Time to response
Time frame: Up to day 28
Time to negative
Time frame: Up to day 28
Percentage of subjects with disappearance of clinical symptoms
Time frame: Up to day 28
Change in COVID-19 symptom score
Time frame: Up to day 28
Ct value change from baseline
Time frame: Up to day 28
Change from baseline in chest CT scan (optional)
Time frame: Up to day 28
Percentage of Subjects Progressed
Time frame: Up to day 28
Percent of Subjects Who Died
Time frame: Up to day 28
Safety Assessment Results
Time frame: Up to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhou Lu, ph.D principal investigator
Shenzhen Third People 's Hospital
Rui Song principal investigator
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHEN211 Tablets in people with COVID-19, run by JKT Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, ph.D (0755-61232898, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SARS-CoV-2 viral load at each time point (time frame: Up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.