Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Low-dose group:Low-dose hydroxychloroquine and conventional therapy
Medium-dose group:Medium-dose hydroxychloroquine and conventional therapy
High-dose group:High-dose hydroxychloroquine and conventional therapy
control group:conventional therapy
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects who meet the following conditions can become subjects of this study: 1. Sign written informed consent. Adolescents or patients who cannot sign informed consent must obtain informed consent from the guardian; 2. Chinese who are >= 18 years of age; 3. It complies with the diagnostic criteria for NCP diagnosis of common patients, that is, the "Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Fifth Edition)". Comprehensive analysis based on the following epidemiological history, clinical manifestations and etiological examination: a. Epidemiological history (1)Travel history or residence history of Wuhan and surrounding areas or other communities with case reports within 14 days before the onset of illness; (2)Have a history of contact with a new coronavirus infected person (positive nucleic acid test) within 14 days before the onset of illness; (3)Patients with fever or respiratory symptoms from Wuhan and surrounding areas or from communities with case reports within 14 days before the onset of illness; (4)Aggressive onset; b. clinical manifestations (1)Fever and / or respiratory symptoms; (2)NCP imaging features (early multiple small patchy shadows and interstitial changes, obvious in the extrapulmonary zone. Then developed into multiple lungs with ground glass and infiltrates. In severe cases, pulmonary consolidation and pleural effusion Rare (3)The total number of early white blood cells is normal or decreased, or the lymphocyte count is decreased. c. Real-time fluorescent RT-PCR of respiratory or blood specimens for detection of novel coronavirus nucleic acid; NCP confirmed case criteria: (1)Have any one of the epidemiological history, and meet any two of the clinical manifestations, and at the same time, the pathogenic test is positive; (2)If there is no clear epidemiological history, it meets any three of the clinical manifestations, and at the same time, the pathogenic examination is positive. 4. The course of disease is within 10 days after the onset of illness; 5. Will take nasopharyngeal or oropharyngeal swabs before administration.
Exclusion criteria
Exclusion criteria: Patients with any of the following were excluded from the study: 1. Patients with previous allergy to 4-aminoquinoline compounds; 2. Patients with previous severe retinal or visual field related diseases; 3. Patients with severe liver dysfunction and patients with renal dysfunction (creatinine clearance rate <= 50 mL / min); 4. Patients weighing <35kg; 5. Patients exposed to other study drugs within 30 days before administration; 6. Being pregnant or breastfeeding. Or have a pregnancy plan (including partner) within one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative conversion rate of 2019-nCoV nucleic acid ;Lung inflammation absorption ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for body temperature to return to normal;Time of improvement in respiratory symptoms;Time to turn critical;Days in hospital;Frequency of serious adverse events; | — |
Countries
China
Contacts
Public ContactWenxiang Huang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed