Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

Study Overview
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Brief Summary
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This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150. 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.

Official Title
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Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

Conditions
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Novel Coronavirus Pnuemonia

Intervention / Treatment
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* Drug: favipiravir tablets+chloroquine phosphatetablets tablets
* Drug: Favipiravir tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, 18-75 years old 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: Severe vomiting or difficulty ingesting medication 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: favipiravir tablets+chloroquine phosphatetablets tablets group<br>favipiravir tablets+chloroquine phosphatetablets tablets | Drug: favipiravir tablets+chloroquine phosphatetablets tablets<br>* 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.<br>|
| Experimental: favipiravir tablets group<br>favipiravir tablets | Drug: Favipiravir tablets<br>* 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.<br>|
| Placebo Comparator: placebo treatment group<br>placebo | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Improvement or recovery of respiratory symptoms | Time of improvement or recovery of respiratory symptoms | 10 days during the intervention period | 
| Number of days virus nucleic acid shedding | Number of days from positive to negative for test of swab or sputum virus nucleic acid | 10 days during the intervention period | 
| Frequency of Improvement or recovery of respiratory symptoms | Frequency of improvement or recovery of respiratory symptoms | 10 days during the intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of fever | Duration of fever after recruitment | 10 days during the intervention period | 
| Frequencies of progression to severe illness | Disease is defined as severe if it meets any of the following criteria: 1.Respiratory rate ≥30/min; 2. Oxygen saturation ≤93%; 3. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) ≤300 mmHg (1 mmHg=0.133 kPa) | 10 days during the intervention period | 
| Time of improvement of pulmonary imaging | Time of improvement of pulmonary imaging | 10 days during the intervention period | 
| Peripheral blood c-reactive protein concentration | Peripheral blood c-reactive protein concentration | day-1,3,7,14 after the intervention period | 
| Absolute value of peripheral blood lymphocytes | Absolute value of peripheral blood lymphocytes | day-1,3,7,14 after the intervention period | 
| percentage of peripheral blood lymphocytes | percentage of peripheral blood lymphocytes | day-1,3,7,14 after the intervention period |