Condition or disease | Intervention/treatment | Phase |
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Influenza A | Drug: ZSP1273 200 mg Drug: Placebo Drug: ZSP1273-400 mg Drug: ZSP1273-600 mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 172 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A |
Actual Study Start Date : | December 7, 2019 |
Actual Primary Completion Date : | May 18, 2020 |
Actual Study Completion Date : | May 18, 2020 |
Arm | Intervention/treatment |
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Experimental: ZSP1273-200 mg BID
Subjects will receive 10 doses of ZSP1273 200mg along with placebo twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
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Drug: ZSP1273 200 mg
1 X 200-mg tablet taken orally
Drug: Placebo 2 tablets taken orally
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Experimental: ZSP1273-400 mg BID
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.
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Drug: ZSP1273-400 mg
2 X 200-mg tablet taken orally
Drug: Placebo 1 tablet taken orally
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Experimental: ZSP1273-600 mg QD
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) .
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Drug: ZSP1273-600 mg
3 X 200-mg tablet taken orally
Drug: Placebo 3 tablets taken orally
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Placebo Comparator: Placebo
Subjects will receive 10 doses of matching placebo of ZSP1273 twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5 days.
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Drug: Placebo
Subjects will receive matching placebo of ZSP1273
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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
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.
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.
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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with a diagnosis of influenza virus A infection confirmed by all of the following:
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:
The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:
Exclusion Criteria:
Use of the following medications within 7 days prior to screening:
Tracking Information | |||||
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First Submitted Date ICMJE | July 10, 2019 | ||||
First Posted Date ICMJE | July 18, 2019 | ||||
Last Update Posted Date | June 4, 2020 | ||||
Actual Study Start Date ICMJE | December 7, 2019 | ||||
Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A | ||||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of ZSP1273 in Adults With Acute Uncomplicated Influenza A | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Influenza A | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
172 | ||||
Original Estimated Enrollment ICMJE |
400 | ||||
Actual Study Completion Date ICMJE | May 18, 2020 | ||||
Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04024137 | ||||
Other Study ID Numbers ICMJE | ZSP1273-18-02 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Guangdong Raynovent Biotech Co., Ltd | ||||
Study Sponsor ICMJE | Guangdong Raynovent Biotech Co., Ltd | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Guangdong Raynovent Biotech Co., Ltd | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |