Novel Coronavirus Pnuemonia Clinical Trial
Official title:
Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | June 25, 2020 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Chaoyang hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Chao Yang Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time of Improvement or recovery of respiratory symptoms | Time of improvement or recovery of respiratory symptoms | 10 days during the intervention period | |
| Primary | 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 | |
| Primary | Frequency of Improvement or recovery of respiratory symptoms | Frequency of improvement or recovery of respiratory symptoms | 10 days during the intervention period | |
| Secondary | Duration of fever | Duration of fever after recruitment | 10 days during the intervention period | |
| Secondary | 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 | |
| Secondary | Time of improvement of pulmonary imaging | Time of improvement of pulmonary imaging | 10 days during the intervention period | |
| Secondary | Peripheral blood c-reactive protein concentration | Peripheral blood c-reactive protein concentration | day-1,3,7,14 after the intervention period | |
| Secondary | Absolute value of peripheral blood lymphocytes | Absolute value of peripheral blood lymphocytes | day-1,3,7,14 after the intervention period | |
| Secondary | percentage of peripheral blood lymphocytes | percentage of peripheral blood lymphocytes | day-1,3,7,14 after the intervention period |