Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Control group:none
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female, older than 18 years; 2. Patients with confirmed COVID19; 3. Need to continue the antivirus therapy; 4. Agree to sign the informed consent; 5. Able to ingest, absorb and tolerate oral medication; 6. Agree to collect clinical samples; 7. Consent to contraceptive measures for sex within 7 days of the last oral medication.
Exclusion criteria
Exclusion criteria: 1. Cases with severe vomiting and difficulty in taking drugs orally or causing difficulty in taking drugs after oral administration; 2. Pregnant and lactating women; 3. The subjects participated other clinical trials within 30 days before admission; 4. Cases with no hope of survival, hospice care only, or deep coma and no response to supportive treatment within three hours after admission; 5. Cases of deep shock and respiratory failure; 6. Severe liver diseases (such as child Pugh score >= C, AST more than 5 times of the upper limit of normal); 7. Patients with severe renal insufficiency (estimated glomerular filtration rate <= 30ml / min / 1.73m2) or undergoing continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 8. Patients with known allergic reactions or contraindications to chloroquine phosphate; 9. The doctor decided that it was not in the best interests of the subjects to participate in the study, or there was any situation in which the agreement could not be followed safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality;Frequency of exacerbation of dyspnea;Remission time of non-primary symptoms;Time for 2019-nCoV nucletic acid turning negtive in throat swabs;Duration of oxygen inhalation or noninvasive ventilation;Viral load in throat swabs in first and seventh day;Viral load in anal swabs before discharge or at the end of the study;Anti-2019-nCoV IgG and IgM values in serum in first, seventh, fourteenth day, before discharge and at the end of the study;Improved BAP-65 and DECAF scores in first and seventh day;Blood routine, blood gas analysis, liver and kidney function and blood drug concentration of chloroquine phosphate in first and seventh day;Days of mechanical ventilation;Time for recovery in images;The incidence of progression to critical illness or death;Length-of-stay in hospital and/or ICU;Cost of money;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactZhao Yan
Zhongnan Hospital of Wuhan University
Outcome results
None listed