Influenza APhase 2NCT04024137
Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A
A Phase 2 study testing ZSP1273 200 mg, ZSP1273-400 mg and ZSP1273-600 mg in people with Influenza A, run by Guangdong Raynovent Biotech Co., Ltd at 26 sites in China.
Trial summary
The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza A
- What is being tested?
- ZSP1273 200 mg, ZSP1273-400 mg and ZSP1273-600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 26 sitesChina
- Study dates
- 7 Dec 2019to 18 May 2020
- 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
- Males and female subjects between 18-65 years (Both inclusive).
- Patients with a diagnosis of influenza virus A infection confirmed by all of the following:
- Positive Rapid Antigen Test (RAT) with throat swabs;and
- Fever≥38.0ºC (axillary) in the predose examinations;and
- At least one of the following general systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:
- General systemic symptoms:Headache,Feverishness or chills,Muscle or joint pain,Fatigue;
Show all 12Show fewer
- Respiratory symptoms:Cough,Sore throat,Nasal congestion.
- The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:
- Time of the first increase in body temperature(axillary temperature≥38.0ºC),or
- Time when the patient experiences at least one general or respiratory symptom.
- Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
Who cannot join
- Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to ZSP1273;
- Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- Use of the following medications within 7 days prior to screening:
- Influenza antiviral medication:oseltamivir,peramivir,famivir,abidol,amantadine or rimantadine.
- Chinese patent medicine or herbal medicine with antiviral effect.
- Patients who have received influenza vaccine within 6 months prior to enrollment.
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- Presence of clinically significant abnormalities in ECG .
- Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
- Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
- White blood cells(WBC)>10.0×109/L at screening.
- Subject who produces purulent sputum or has suppurative tonsillitis.
- Patients with severe or uncontrollable underlying diseases:blood disorders,severe chronic obstructive pulmonary disease(COPD),liver disorders(ALT or AST≥3 ULN,total bilirubin≥1.5 ULN),kidney disorders(serum creatinine>177μmol/L or 2mg/dL),chronic congestive heart failure(NYHA III-IV),mental disorders.
- Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
- Concomitant therapy with aspirin or salicylic acid.
- Morbid obesity(Body mass index [BMI]≥30kg/m2).
- Known history of alcohol abuse or drug abuse.
- Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
- Have received any other investigational products within 3 months prior to dosing.
- Subjects who should not be included in the study in the opinion of the Investigator.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality
Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
Chengdu Fifth People's Hospital
Chengdu, Sichuan
Dongguan people's Hospital
Dongguan, Guangdong
Nanfang Hospital,South Medical Hospital
Guangzhou, Guangdong
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong
Traditional Chinese Medicine Hospital of Guangdong Province
Guangzhou, Guangdong
The First Affiliated Hospital,Zhejiang University
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
The Second Hospital Of Anhui Medical University
Hefei, Anhui
Huizhou Municipal Central Hospital
Huizhou, Guangdong
Jieyang People's Hospital
Jieyang, Guangdong
Jiujiang University Hospital
Jiujiang, Jiangxi
Linyi People's Hospital
Linyi, Shandong
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu
Qingdao Municipal Hospital
Qingdao, Shandong
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Shenzhen People's Hospital
Shenzhen, Guangdong
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Affiliated Hospital Of Guangdong Medical University
Zhanjiang, Guangdong
Henan Provincial People's Hospital
Zhengzhou, Henan
The Sixth People's Hospital Of Zhengzhou
Zhengzhou, Henan
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A
The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273.
- Conditions
- Influenza A
- Being tested
- ZSP1273 200 mg, Placebo, ZSP1273-400 mg, ZSP1273-600 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273 200 mgDrug
1 X 200-mg tablet taken orally
PlaceboDrug
2 tablets taken orally
ZSP1273-400 mgDrug
2 X 200-mg tablet taken orally
PlaceboDrug
1 tablet taken orally
ZSP1273-600 mgDrug
3 X 200-mg tablet taken orally
PlaceboDrug
3 tablets taken orally
PlaceboDrug
Subjects will receive matching placebo of ZSP1273
| Study group | Role | What they receive |
|---|---|---|
| ZSP1273-200 mg BID | Experimental | Subjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. Receives: Drug: ZSP1273 200 mg; Drug: Placebo |
| ZSP1273-400 mg BID | Experimental | Subjects will receive 10 doses of ZSP1273 400mg（200mg*2) along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. Receives: Drug: ZSP1273-400 mg; Drug: Placebo |
| ZSP1273-600 mg QD | Experimental | Subjects will receive 5 doses of ZSP1273 600mg （200mg *3) and 5 doses of placebo respectively for 5 days.The interval between ZSP1273 and placebo is approximately 12 hour (+/- 2) . Receives: Drug: ZSP1273-600 mg; Drug: Placebo |
| Placebo | Placebo comparator | Subjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alleviation of influenza symptoms in participants
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all 7 influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
Measured: Initiation of study treatment (Day 1) up to Day 15
Secondary outcomes (14)
AUC of the log10 pharyngeal viral load
Area under the curve (AUC) of the log10 pharyngeal viral load is measured by viral culture and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
Measured: Days 6
Change in the total score of 7 influenza symptoms
Participants assessed the severity of seven influenza-associated symptoms(cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
The composite symptom score is the total score of the 7 influenza symptoms(Sum of symptom scores) as assessed by the participant, and ranges from 0 to 21.
Measured: Up to Day15
Time to alleviation of each influenza symptom.
Participants assessed the severity of seven influenza-associated symptoms(cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Measured: Up to Day15
Time to Resolution of Fever
Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours.
Measured: Up to Day15
Proportion of patients reporting normal temperature
Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment.
Measured: Up to Day15
Percentage of subjects with virus titer detected
Influenza virus RNA was quantified from throat swabs.Proportion of patients positive for influenza virus titer is defined as the percentage of patients whose virus titer is not less than the lower limit of quantification among those assessed for virus titer measured by viral culture and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) on Days 2,4, 6.
Measured: Days 2,4, 6
Duration of detectable virus
Defined as the time from the start of treatment to the time when the titer is less than the lower limit of quantification measured by viral culture and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
Measured: Days 2,4, 6
Change in virus titer
Defined as the change from baseline in virus titer measured by viral culture and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
Measured: Days 2,4, 6
Change in viral RNA load
Defined as the change from baseline in viral RNA load measured by viral culture and quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) on Days 2, 4, 6.
Measured: Days 2,4, 6
Incidence of influenza-related complications
Defined as the percentage of subjects in the analysis population who experience each influenza-related complication (sinusitis, otitis media, bronchitis, and pneumonia) as an adverse event after the initiation of the study treatment.
Measured: Up to Day21
Time to return to normal activities of daily life
Participants were asked to record their activities of daily life on a scale from 0 (worst possible health) to 10 (normal activities of daily life).
Time to return to normal activities of daily life defined as the time between the initiation of the study treatment and the return to normal activities of daily life. The return to normal activities of daily life is defined as the time when the subject assesses his/her activities as 10.Subjects with a baseline self-rated daily activity score of 10 are not included in this analysis.
Measured: Up to Day15
Proportion of patients with the Serological conversion of neutralizing antibody titer relative to that in Visit 1 ≥4
Defined as the protprtion of patients with a ratio of 4 or more at Visit 5 antibody titer relative to Visit 1 titer
Measured: Baseline and Day 21
Proportion of patients and frequency in combination use of acetaminophen.
The proportion of patients who use acetaminophen in the duration of the study
Measured: Up to 21 days post-dose
Change in EQ-5D-5L
Defined as the change from baseline in the index value and that in EQ VAS score as calculated from the EQ-5D-5L questionnaire.
Measured: Baseline up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start7 Dec 2019
- Primary completion18 May 2020
- Study completion18 May 2020
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 Influenza AStudies 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024137
- Sponsor's protocol ID
- ZSP1273-18-02
- Status last verified
- Dec 2019
- First submitted
- 10 Jul 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Z, Li Z, Zhan Y, Lin Z, Fang Z, Xu X, Lin L, Li H, Lin Z, Kang C, Liang J, Liang S, Li Y, Li S, Yang X, Ye F, Zhong N; Onradivir Trial Recruitment and Medical Monitoring Group. Safety and efficacy of onradivir in adults with acute uncomplicated influenza A infection: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2024 May;24(5):535-545. doi: 10.1016/S1473-3099(23)00743-0. Epub 2024 Feb 5.
PubMed 38330975
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A
- ClinicalTrials.gov ID
- NCT04024137
- Acronym / sponsor ID
- ZSP1273-18-02
- Conditions
- Influenza A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 18 Jul 2019 (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.
The purpose of this study is to evaluate the antiviral effect, as measured by the time to alleviation of influenza symptoms and viral titer in nasopharyngeal secretions in adults with acute uncomplicated influenza A following administration of ZSP1273.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZSP1273-200 mg BID | Experimental | Drug: ZSP1273 200 mg, Drug: PlaceboSubjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. |
| ZSP1273-400 mg BID | Experimental | Drug: ZSP1273-400 mg, Drug: PlaceboSubjects will receive 10 doses of ZSP1273 400mg（200mg*2) along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. |
| ZSP1273-600 mg QD | Experimental | Drug: ZSP1273-600 mg, Drug: PlaceboSubjects will receive 5 doses of ZSP1273 600mg （200mg *3) and 5 doses of placebo respectively for 5 days.The interval between ZSP1273 and placebo is approximately 12 hour (+/- 2) . |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and female subjects between 18-65 years (Both inclusive).
- Patients with a diagnosis of influenza virus A infection confirmed by all of the following:
- The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:
- Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
Key exclusion criteria (19 listed)
- Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to ZSP1273;
- Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- Use of the following medications within 7 days prior to screening:
- Patients who have received influenza vaccine within 6 months prior to enrollment.
- Presence of clinically significant abnormalities in ECG .
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 |
|---|---|---|
| ZSP1273 200 mg1 X 200-mg tablet taken orally | Drug | ZSP1273-200 mg BID |
| Placebo2 tablets taken orally | Drug | ZSP1273-200 mg BID |
| ZSP1273-400 mg2 X 200-mg tablet taken orally | Drug | ZSP1273-400 mg BID |
| Placebo1 tablet taken orally | Drug | ZSP1273-400 mg BID |
| ZSP1273-600 mg3 X 200-mg tablet taken orally | Drug | ZSP1273-600 mg QD |
| Placebo3 tablets taken orally | Drug | ZSP1273-600 mg QD |
| PlaceboSubjects will receive matching placebo of ZSP1273 | Drug | Placebo |
Primary outcome
Time to alleviation of influenza symptoms in participants
Time frame: Initiation of study treatment (Day 1) up to Day 15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all 7 influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours
14 secondary outcomes
AUC of the log10 pharyngeal viral load
Time frame: Days 6
Change in the total score of 7 influenza symptoms
Time frame: Up to Day15
Time to alleviation of each influenza symptom.
Time frame: Up to Day15
Time to Resolution of Fever
Time frame: Up to Day15
Proportion of patients reporting normal temperature
Time frame: Up to Day15
Percentage of subjects with virus titer detected
Time frame: Days 2,4, 6
Duration of detectable virus
Time frame: Days 2,4, 6
Change in virus titer
Time frame: Days 2,4, 6
Change in viral RNA load
Time frame: Days 2,4, 6
Incidence of influenza-related complications
Time frame: Up to Day21
Time to return to normal activities of daily life
Time frame: Up to Day15
Proportion of patients with the Serological conversion of neutralizing antibody titer relative to that in Visit 1 ≥4
Time frame: Baseline and Day 21
Proportion of patients and frequency in combination use of acetaminophen.
Time frame: Up to 21 days post-dose
Change in EQ-5D-5L
Time frame: Baseline up to Day 15
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 4 Jun 2020.
- Derived from this study: PubMed 38330975Yang Z, Li Z, Zhan Y, Lin Z, Fang Z, Xu X, Lin L, Li H, Lin Z, Kang C, Liang J, Liang S, Li Y, Li S, Yang X, Ye F, Zhong N; Onradivir Trial Recruitment and Medical Monitoring Group. Safety and efficacy of onradivir in adults with acute uncomplicated influenza A infection: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2024 May;24(5):535-545. doi: 10.1016/S1473-3099(23)00743-0. Epub 2024 Feb 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 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 ZSP1273 200 mg, ZSP1273-400 mg and ZSP1273-600 mg in people with Influenza A, run by Guangdong Raynovent Biotech Co., Ltd at 26 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 19 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Time to alleviation of influenza symptoms in participants (time frame: Initiation of study treatment (Day 1) up to 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 NCT04024137, 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 4 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.