COVID-19Phase 2NCT05676073
Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
A Phase 2 study testing SHEN26 dose 1 and SHEN26 dose 2 in people with COVID-19, run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- SHEN26 dose 1 and SHEN26 dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 4 sitesChina
- Study dates
- 8 Dec 2022to 27 Jan 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the trial's purpose, nature, methods, and possible adverse effects, volunteer as a subject, and sign the informed consent form.
- Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and pledge to use one or more non-pharmacological contraceptives during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug.
- Age 18-65 years (including boundary values, based on the time of signing the informed consent form) of either sex.
- Positive results for SARS-CoV-2 using RT-PCR (Ct value< 25) in nasopharyngeal swab samples with the first positive nucleic acid test collected ≤ 5 days from Day 1 administration.
- Patients with a diagnosis of mild or moderate COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9).
- Liver function indicators meet the criteria of：
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- Alanine aminotransferase (ALT) ≤ 3 × ULN;
- Aspartate aminotransferase (AST) ≤ 3 × ULN;
- Total bilirubin (TBIL) ≤ 2 × ULN.
- Hemoglobin (Hb) ≥ 90 g/L.
- Platelets ≥ 100 × 10^9 /L.
- Blood creatinine converted endogenous creatinine clearance (Ccr) > 60 mL/min (according to the Cockcroft-Gault formula).
Who cannot join
- Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization.
- Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment.
- Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing.
- Subjects who require mechanical ventilation or are expected to require mechanical ventilation.
- Subjects infected with COVID-19 within 3 months prior to dosing.
- Subjects who have received SARS-CoV-2 monoclonal antibody treatment or prophylaxis within 30 days prior to dosing.
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- Subjects who have received COVID-19 convalescent plasma or COVID-19 human immunoglobulin treatment within 30 days prior to dosing.
- Subjects who have received treatment or prophylaxis with antiviral drugs (e.g., Paxlovid, Molnupiravir, Remdesivir, lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine, etc.) within 30 days prior to dosing.
- Subjects who have received systemic or inhaled steroids for COVID-19 treatment within 30 days prior to dosing (except for long-term stable dose treatment with concomitant chronic disease and no dose increase).
- Subjects who are on dialysis.
- Subjects with a history of drug or other allergies or who, in the investigator's judgment, may be allergic to the test drug or any component of the test drug.
- Subjects who have undergone major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days prior to dosing or who require elective surgery during the trial period.
- Subjects with a life-threatening illness within 28 days prior to dosing, or other clinically significant illness as judged by the investigator.
- Cardiovascular disease meeting any of the following criteria:
- Prior history of myocardial infarction within 12 months;
- Unstable angina pectoris;
- Clinically significant and uncontrollable cardiac arrhythmia;
- A history of stroke or transient ischemic attack requiring medication in the past 12 months;
- Congestive heart failure based on NYHA classification ≥ Class II;
- Restrictive edema of ≥ grade 3 (including respiratory, chest and mediastinal disease: laryngeal edema, pulmonary edema; skin and subcutaneous tissue disease: peripheral edema);
- Clinically uncontrollable hypertension.
- Subjects with suspected or confirmed active systemic infections, such as bacterial, fungal, viral or other infections (other than COVID-19 infections), or with conditions that, in the investigator's judgment, would affect the assessment of endpoints in this study.
- Subjects with known HIV infection, or human immunodeficiency virus antibody (HIV-Ab) positive at screening.
- Subjects with liver disease meeting any of the following criteria:
- Known active HBV infection (subjects with a history of hepatitis B or previous hepatitis B surface antigen positivity but whose liver function at baseline meets the inclusion criteria and is judged by the investigator to be stable may be enrolled);
- Known HCV infection;
- Primary biliary cirrhosis;
- Child-Pugh Class B or C;
- Acute liver failure.
- Subjects who have difficulty with venous blood collection or have a history of acupuncture and blood sickness.
- Female subjects who have tested positive for pregnancy or are breastfeeding during the screening or baseline period.
- Subjects who have participated in other drug clinical trials and used other clinical trial drugs within 1 month prior to screening.
- Subjects who have received any vaccine within 1 month prior to screening or subjects who are scheduled to receive vaccines (including COVID-19 vaccine boosters) during the trial.
- Any other circumstances that, in the investigator's opinion, may affect the subject's ability to provide informed consent or follow the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518112
Shenzhen Longhua District People's Hospital
Shenzhen, Guangdong
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei
About this study
Official title: A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19.
Read the detailed description
Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30 patients in each group.
- Conditions
- COVID-19
- Being tested
- SHEN26 dose 1, SHEN26 dose 2, 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 dose 1Drug
Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
SHEN26 dose 2Drug
Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
SHEN26 placeboDrug
Placebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6).
| Study group | Role | What they receive |
|---|---|---|
| SHEN26 dose 1 | Experimental | SHEN26 capsule 200mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). Receives: Drug: SHEN26 dose 1 |
| SHEN26 dose 2 | Experimental | SHEN26 capsule 400mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). Receives: Drug: SHEN26 dose 2 |
| SHEN26 placebo | Placebo comparator | Placebo matching the SHEN26 capsule. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). Receives: Drug: SHEN26 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Measured: Day 7
Secondary outcomes (11)
TEAEs and SAEs
The incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs).
Measured: From Baseline up to Day 28
AEs leading to discontinuation of treatment
The incidence of AEs leading to discontinuation of study treatment.
Measured: From Baseline up to Day 28
Drug-related treatment discontinuation
The incidence of drug-related study treatment discontinuation.
Measured: From Baseline up to Day 28
New AEs of Grade 3 or higher
The incidence of new Grade 3 or higher AE (not present at baseline).
The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Measured: From Baseline up to Day 28
New drug-related AEs of Grade 3 or higher
Incidence of new drug-related AEs of Grade 3 or higher.
The investigator should classify the severity of adverse events (AEs) into Grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 1 being the least severe and Grade 5 the most.
Measured: From Baseline up to Day 28
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR)
Measured: Day 3, Day 5, Day 7, Day 10, Day 28
Time to achieve SARS-CoV-2 viral clearance
Viral clearance is defined as two consecutive viral nucleic acid assays with Ct values ≥35 for both N and ORF genes by RT-PCR and an interval of ≥24 hours between sampling. The date of achieving clearance is calculated as the date of the first Ct value ≥ 35).
Measured: From Baseline up to Day 28
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints
The change in percentage of participants achieving SARS-CoV-2 viral clearance.
Measured: Day 3, Day 5, Day 7, Day 10, Day 28
Plasma concentrations of SHEN26-69-0 on Day 5
Measured: Day 5
Time to achieve sustained alleviation of COVID-19 symptoms
Time to achieve sustained alleviation of 11 symptoms of COVID-19 after the first dose, with sustained alleviation defined as a related symptom score of 0 to 1 and lasting ≥ 48 hours.
The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Measured: From Day 1 up to Day 28
Time to achieve sustained recovery of COVID-19 symptoms
Time to achieve sustained recovery of 11 symptoms of COVID-19 after the first dose, with sustained recovery defined as a relevant symptom score of 0 and lasting ≥ 48 hours.
The severity of symptoms will be scored according to the COVID-19 Major Symptoms and Rating Scale, with 0 being the least severe and 3 being the most.
Measured: From Day 1 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 posted9 Jan 2023
- Study start8 Dec 2022
- Primary completion30 Dec 2022
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hongzhou Lu, MD, PhD, Principal investigator, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676073
- Sponsor's protocol ID
- KXZY-SHEN26-101-Phase-II
- Status last verified
- Jun 2023
- First submitted
- 3 Jan 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai J, Asakawa T, Yuan W, Lin Y, Ju H, Xu D, Yang M, Li S, Li G, Guo D, Lu H, Zhang X. Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Virol J. 2025 Jan 25;22(1):16. doi: 10.1186/s12985-025-02631-y.
PubMed 39863888
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHEN26 Capsule in Patients With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05676073
- Acronym / sponsor ID
- KXZY-SHEN26-101-Phase-II
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.Research network
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 9 Jan 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 II clinical trial. It is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules in Chinese patients with mild to moderate COVID-19.
Detailed description
Eligible patients with mild to moderate COVID-19 will be randomized in a 1:1:1 ratio to SHEN26 low dose group (200 mg), SHEN26 high dose group (400 mg), and placebo group, with 30 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHEN26 dose 1 | Experimental | Drug: SHEN26 dose 1SHEN26 capsule 200mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). |
| SHEN26 dose 2 | Experimental | Drug: SHEN26 dose 2SHEN26 capsule 400mg. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). |
| SHEN26 placebo | Placebo comparator | Drug: SHEN26 placeboPlacebo matching the SHEN26 capsule. 10 oral doses twice daily (after breakfast and dinner; Q12h±2h). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Fully understand the trial's purpose, nature, methods, and possible adverse effects, volunteer as a subject, and sign the informed consent form.
- Subjects and their female partners are willing to have no childbearing plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and pledge to use one or more non-pharmacological contraceptives during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug.
- Age 18-65 years (including boundary values, based on the time of signing the informed consent form) of either sex.
- Positive results for SARS-CoV-2 using RT-PCR (Ct value< 25) in nasopharyngeal swab samples with the first positive nucleic acid test collected ≤ 5 days from Day 1 administration.
- Patients with a diagnosis of mild or moderate COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9).
Key exclusion criteria (34 listed)
- Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization.
- Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment.
- Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing.
- Subjects who require mechanical ventilation or are expected to require mechanical ventilation.
- Subjects infected with COVID-19 within 3 months prior to dosing.
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 dose 1Specification: 200mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6). | Drug | SHEN26 dose 1 |
| SHEN26 dose 2Specification: 400mg/capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6). | Drug | SHEN26 dose 2 |
| SHEN26 placeboPlacebo matching the SHEN26 capsule. Subjects will receive 10 oral doses twice daily (after breakfast and dinner; Q12h±2h) from Day 1 to Day 5 (or Day 1 to Day 6). | Drug | SHEN26 placebo |
Primary outcome
SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
Time frame: Day 7
Change from baseline in SARS-CoV-2 viral RNA level (RT-PCR) on Day 7
11 secondary outcomes
TEAEs and SAEs
Time frame: From Baseline up to Day 28
AEs leading to discontinuation of treatment
Time frame: From Baseline up to Day 28
Drug-related treatment discontinuation
Time frame: From Baseline up to Day 28
New AEs of Grade 3 or higher
Time frame: From Baseline up to Day 28
New drug-related AEs of Grade 3 or higher
Time frame: From Baseline up to Day 28
SARS-CoV-2 viral RNA level (RT-PCR) at prespecified timepoints
Time frame: Day 3, Day 5, Day 7, Day 10, Day 28
Time to achieve SARS-CoV-2 viral clearance
Time frame: From Baseline up to Day 28
Percentage of participants achieving SARS-CoV-2 viral clearance at prespecified timepoints
Time frame: Day 3, Day 5, Day 7, Day 10, Day 28
Plasma concentrations of SHEN26-69-0 on Day 5
Time frame: Day 5
Time to achieve sustained alleviation of COVID-19 symptoms
Time frame: From Day 1 up to Day 28
Time to achieve sustained recovery of COVID-19 symptoms
Time frame: From Day 1 up to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 39863888Bai J, Asakawa T, Yuan W, Lin Y, Ju H, Xu D, Yang M, Li S, Li G, Guo D, Lu H, Zhang X. Efficacy and safety of SHEN26, a novel oral small molecular RdRp inhibitor for COVID-19 treatment: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Virol J. 2025 Jan 25;22(1):16. doi: 10.1186/s12985-025-02631-y.
- 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, MD, PhD principal investigator
Shenzhen Third People's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHEN26 dose 1 and SHEN26 dose 2 in people with COVID-19, run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 4 sites 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 12 inclusion and 34 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: finished, as of the sponsor's last update on 18 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 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 viral RNA level (RT-PCR) on Day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05676073, which also lists 1 linked publication.
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 18 Jun 2023.