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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
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: 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 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.
Beijing Chaoyang hospital
Beijing, Beijing Municipality, China
RECRUITINGTime of Improvement or recovery of respiratory symptoms
Time of improvement or recovery of respiratory symptoms
Time frame: 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
Time frame: 10 days during the intervention period
Frequency of Improvement or recovery of respiratory symptoms
Frequency of improvement or recovery of respiratory symptoms
Time frame: 10 days during the intervention period
Duration of fever
Duration of fever after recruitment
Time frame: 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)
Time frame: 10 days during the intervention period
Time of improvement of pulmonary imaging
Time of improvement of pulmonary imaging
Time frame: 10 days during the intervention period
Peripheral blood c-reactive protein concentration
Peripheral blood c-reactive protein concentration
Time frame: day-1,3,7,14 after the intervention period
Absolute value of peripheral blood lymphocytes
Absolute value of peripheral blood lymphocytes
Time frame: day-1,3,7,14 after the intervention period
percentage of peripheral blood lymphocytes
percentage of peripheral blood lymphocytes
Time frame: day-1,3,7,14 after the intervention period
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