COVID-19Phase 3NCT05908071
Study Evaluating SHEN26 Capsule in Patients With Mild to Moderate COVID-19
A Phase 3 study testing SHEN26 capsule in people with COVID-19, run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19 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?
- SHEN26 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2023to Jul 2024
- Phase
- Phase 3
- 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
- Participants ≥18 years of age, male or female.
- The subjects were classified as mild or moderate COVID-19, confirmed SARS-CoV-2 infection 72 hours prior to randomization.
- Initial onset 2 of 11 COVID-19 symptoms within 72 hours before randomization, respiratory and feverish symptoms must be included.
- Female subjects of childbearing age must have a negative urine pregnancy test during the screening.Fertile participants must agree to take effective contraceptive measures.
- Understand the procedures and methods of this clinical trial, after fully informed and they participate voluntarily and sign the informed consent form.
Who cannot join
- Known hypersensitivity to any ingredient in the experimental drug.
- Patients with severe or critical COVID-19.
- With abnormal liver function observed at the time of screening: total bilirubin ≥ 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.
- Subjects with liver diseases, including but not limited to the following diseases, which may affect the safety or efficacy evaluation of subjects during the trial as assessed by the investigator:primary biliary cirrhosis、Child-Pugh Class B or C、acute liver failure.
- Subjects with known human immunodeficiency virus (HIV) infection.
- Abnormal renal function observed at the time of screening: serum creatinine ≥ 1.5×ULN;or patients receiving continuous renal replacement therapy, hemodialysis, and peritoneal dialysis at the time of screening.
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- Subjects with acute exacerbation of chronic respiratory diseases.
- Suspected or confirmed acute systemic infections other than COVID-19 observed at the time of screening.
- Complications requiring surgery before randomized trial or during the entire trial period and major surgery operated 14 days before the randomized trial,or life-threatening comorbidities considered by the investigator within 30 days before the randomized trial.
- Cardiovascular diseases meeting any of the following criteria:History of myocardial infarction within the past 12 months、Unstable angina、Clinically significant and uncontrollable cardiac arrhythmias、History of stroke or transient ischemic attack requiring drug treatment in the past 12 months、Congestive heart failure of grade ≥ II assessed by New York Heart Association (NYHA)、Localized edema of grade ≥3、Clinically uncontrolled hypertension.
- Received SARS-CoV-2 monoclonal antibody treatment or prevention within 30 days before the randomized trial.
- Received convalescent COVID-19 patient plasma or COVID-19 human immunoglobulin therapy within 30 days before the randomized trial.
- Have taken antiviral drugs within 30 days before the randomized trial.
- Have taken any COVID-19 vaccine within 3 months or have been infected with new coronavirus within 3 months before the randomized trial.
- Pregnant and lactating women.
- Have participated in other clinical trials or are using experimental drugs within 3 months before the randomized trial.
- Under other conditions that are not suitable for participating in this trial assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHEN26 Capsule in Adult Participants With Mild to Moderate COVID-19
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19
- Conditions
- COVID-19
- Being tested
- SHEN26 capsule, SHEN26 placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHEN26 capsuleDrug
Capsule administered orally after meals.
SHEN26 placeboDrug
Capsule administered orally after meals.
| Study group | Role | What they receive |
|---|---|---|
| SHEN26 | Experimental | Participants will receive SHEN26 400mg twice daily for 5 days. Receives: Drug: SHEN26 capsule |
| SHEN26 placebo | Placebo comparator | Participants will receive SHEN26 placebo twice daily for 5 days. Receives: Drug: SHEN26 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 11 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
Measured: Day 1 up to 28
Secondary outcomes (9)
Change of viral load compared to the baseline
Measured: Baseline, Day 3, and Day 5
Time to 5 COVID-19 Symptom Resolution by Day 28
The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days
Measured: Day 1 up to 28
Change of viral load compared to the baseline
Measured: Baseline, Day 7
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Measured: baseline, Day 3, Day 5, and Day 7
Time to sustained alleviation of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days
Measured: Day 1 up to 28
Proportion of Participants with COVID-19 related Hospitalization
Measured: Day 1 up to 28
Proportion of severe or critical Participants
Measured: Day 1 up to 28
Proportion of Participants with All-cause Death
Measured: Day 1 up to 28
AE
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start13 May 2023
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908071
- Sponsor's protocol ID
- KXZY-SHEN26-301
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHEN26 Capsule in Adult Participants With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05908071
- Acronym / sponsor ID
- KXZY-SHEN26-301
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.Research network
- Study start
- 13 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Jun 2023 (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.
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHEN26 | Experimental | Drug: SHEN26 capsuleParticipants will receive SHEN26 400mg twice daily for 5 days. |
| SHEN26 placebo | Placebo comparator | Drug: SHEN26 placeboParticipants will receive SHEN26 placebo twice daily for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants ≥18 years of age, male or female.
- The subjects were classified as mild or moderate COVID-19, confirmed SARS-CoV-2 infection 72 hours prior to randomization.
- Initial onset 2 of 11 COVID-19 symptoms within 72 hours before randomization, respiratory and feverish symptoms must be included.
- Female subjects of childbearing age must have a negative urine pregnancy test during the screening.Fertile participants must agree to take effective contraceptive measures.
- Understand the procedures and methods of this clinical trial, after fully informed and they participate voluntarily and sign the informed consent form.
Key exclusion criteria (17 listed)
- Known hypersensitivity to any ingredient in the experimental drug.
- Patients with severe or critical COVID-19.
- With abnormal liver function observed at the time of screening: total bilirubin ≥ 2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.
- Subjects with liver diseases, including but not limited to the following diseases, which may affect the safety or efficacy evaluation of subjects during the trial as assessed by the investigator:primary biliary cirrhosis、Child-Pugh Class B or C、acute liver failure.
- Subjects with known human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| SHEN26 capsuleCapsule administered orally after meals. | Drug | SHEN26 |
| SHEN26 placeboCapsule administered orally after meals. | Drug | SHEN26 placebo |
Primary outcome
Time to 11 COVID-19 Symptom Resolution by Day 28
Time frame: Day 1 up to 28
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days
9 secondary outcomes
Change of viral load compared to the baseline
Time frame: Baseline, Day 3, and Day 5
Time to 5 COVID-19 Symptom Resolution by Day 28
Time frame: Day 1 up to 28
Change of viral load compared to the baseline
Time frame: Baseline, Day 7
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time frame: baseline, Day 3, Day 5, and Day 7
Time to sustained alleviation of 11 COVID-19 symptoms
Time frame: Day 1 up to 28
Proportion of Participants with COVID-19 related Hospitalization
Time frame: Day 1 up to 28
Proportion of severe or critical Participants
Time frame: Day 1 up to 28
Proportion of Participants with All-cause Death
Time frame: Day 1 up to 28
AE
Time frame: Day 1 up to 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHEN26 capsule in people with COVID-19, run by Shenzhen Kexing Pharmaceutical 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 5 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 22 Jun 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dandan Xu (+8618038100512, xudandan@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 11 COVID-19 Symptom Resolution by Day 28 (time frame: Day 1 up to 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 22 Jun 2023.