InfluenzaPhase 2NCT04736758
A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
A Phase 2 study testing GP681 tablet and GP681 Simulant in people with Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- GP681 tablet and GP681 Simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2021to 18 Dec 2021
- 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
- Positive Influenza rapid antigen test;
- Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
- At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:
- Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
- Respiratory system symptoms: cough, sore throat, nasal congestion.
- Time of disease symptoms ≤48h
Who cannot join
- Diagnosed as severe influenza patient ;
- Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach After subtotal resection, etc.);
- Have used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir dipivoxil, amantadine, or diamond) within 2 weeks before screening Ethylamine, etc.);
- Acute respiratory infections, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis, etc. occurred within 2 weeks before screening, and are in the acute stage;
- Patients who also suffer from bacterial or viral infections and need systemic antibacterial or antiviral therapy
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.
- Conditions
- Influenza
- Being tested
- GP681 tablet, GP681 Simulant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681 tabletDrug
influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.
GP681 SimulantDrug
influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.
| Study group | Role | What they receive |
|---|---|---|
| GP681 tablet 40mg | Experimental | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water. Receives: Drug: GP681 tablet |
| GP681 tablet 20mg | Experimental | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water. Receives: Drug: GP681 tablet |
| Placebo group | Placebo comparator | Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water. Receives: Drug: GP681 Simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to alleviation of influenza symptoms
Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) .
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start8 Jan 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
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 InfluenzaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Cao, phd, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736758
- Sponsor's protocol ID
- GP681-202002
- Status last verified
- Jul 2022
- First submitted
- 27 Jan 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Wang H, Liu D, Ding Y, Zhang M, Xiao Z, Jiang X, Wu Y, Zhang W, Sun S, Chen X, Zhang W, Tang Y, Jiang M, Yang G, Jia W, Wang X, Tong J, Suo L, Yu Y, Yan X, Li Z, Li X, Cao B. Efficacy and safety of single-dose suraxavir marboxil tablet in the treatment of acute uncomplicated influenza in adults: a multi-centre, randomized, double-blind, placebo-controlled phase 2 clinical trial. Clin Microbiol Infect. 2025 May;31(5):861-868. doi: 10.1016/j.cmi.2025.01.025. Epub 2025 Jan 25.
PubMed 39870350
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
- ClinicalTrials.gov ID
- NCT04736758
- Acronym / sponsor ID
- GP681-202002
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 3 Feb 2021 (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.
Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GP681 tablet 40mg | Experimental | Drug: GP681 tabletPatients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water. |
| GP681 tablet 20mg | Experimental | Drug: GP681 tabletPatients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water. |
| Placebo group | Placebo comparator | Drug: GP681 SimulantPatients in the Placebo group is treated with GP681 Simulant orally once with 240mL water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Positive Influenza rapid antigen test;
- Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
- At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:
- Time of disease symptoms ≤48h
Key exclusion criteria (5 listed)
- Diagnosed as severe influenza patient ;
- Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach After subtotal resection, etc.);
- Have used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir dipivoxil, amantadine, or diamond) within 2 weeks before screening Ethylamine, etc.);
- Acute respiratory infections, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis, etc. occurred within 2 weeks before screening, and are in the acute stage;
- Patients who also suffer from bacterial or viral infections and need systemic antibacterial or antiviral therapy
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 |
|---|---|---|
| GP681 tabletinfluenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. | Drug | GP681 tablet 20mg, GP681 tablet 40mg |
| GP681 Simulantinfluenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. | Drug | Placebo group |
Primary outcome
time to alleviation of influenza symptoms
Time frame: Day 15
Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) .
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 26 Jul 2022.
- Derived from this study: PubMed 39870350Wang Y, Wang H, Liu D, Ding Y, Zhang M, Xiao Z, Jiang X, Wu Y, Zhang W, Sun S, Chen X, Zhang W, Tang Y, Jiang M, Yang G, Jia W, Wang X, Tong J, Suo L, Yu Y, Yan X, Li Z, Li X, Cao B. Efficacy and safety of single-dose suraxavir marboxil tablet in the treatment of acute uncomplicated influenza in adults: a multi-centre, randomized, double-blind, placebo-controlled phase 2 clinical trial. Clin Microbiol Infect. 2025 May;31(5):861-868. doi: 10.1016/j.cmi.2025.01.025. Epub 2025 Jan 25.
- 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.
Bin Cao, phd principal investigator
China-Japan Friendship 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 GP681 tablet and GP681 Simulant in people with Influenza, run by Jiangxi Qingfeng 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 6 inclusion and 5 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 26 Jul 2022. 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?
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?
time to alleviation of influenza symptoms (time frame: Day 15). 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 NCT04736758, 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 26 Jul 2022.