Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
NCT ID: NCT04319900
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2020-03-05
2020-06-25
Brief Summary
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During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored.
The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy.
Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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favipiravir tablets+chloroquine phosphatetablets tablets group
favipiravir tablets+chloroquine phosphatetablets tablets
favipiravir tablets+chloroquine phosphatetablets tablets
Favipiravir tablets+ chloroquine phosphate tablets group: 50 patients (anticipated).
Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
Chloroquine phosphate tablets: a total of 1000mg split into two times on day one; from day two to day three, 500mg, once a day; from day four to day ten, 250mg, once a day. Maximum of 10 days for oral administration of the drug.
favipiravir tablets group
favipiravir tablets
Favipiravir tablets
Favipiravir tablets group: 50 patients (anticipated). Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
placebo treatment group
placebo
Placebo
Placebo for favipiravir tablets is produced by Zhejiang Haizheng pharmaceutical co, LTD, batch no. 21812252, Placebo for chloroquine phosphate tablets is produced by the Chinese people's liberation army academy of military science military medical research institute production, batch no. 20200215. All placebos were complied with the quality inspection standard.
Interventions
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favipiravir tablets+chloroquine phosphatetablets tablets
Favipiravir tablets+ chloroquine phosphate tablets group: 50 patients (anticipated).
Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
Chloroquine phosphate tablets: a total of 1000mg split into two times on day one; from day two to day three, 500mg, once a day; from day four to day ten, 250mg, once a day. Maximum of 10 days for oral administration of the drug.
Favipiravir tablets
Favipiravir tablets group: 50 patients (anticipated). Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
Placebo
Placebo for favipiravir tablets is produced by Zhejiang Haizheng pharmaceutical co, LTD, batch no. 21812252, Placebo for chloroquine phosphate tablets is produced by the Chinese people's liberation army academy of military science military medical research institute production, batch no. 20200215. All placebos were complied with the quality inspection standard.
Eligibility Criteria
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Inclusion Criteria
* Patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) No apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) Test for viral nucleic acid positive within 3 days.
* informed consent should be signed by the participate or an authorized agent
* Agree to clinical samples collection
* Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant
Exclusion Criteria
* Woman who are pregnant or during lactation
* Patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment
* Cases of respiratory failure requiring mechanical ventilation
* Shock
* Combined with other organ failure and requires ICU care
* Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission
18 Years
75 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Responsible Party
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Lihong Liu
Prof.
Locations
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Beijing Chaoyang hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-K-24-2
Identifier Type: -
Identifier Source: org_study_id
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