Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Hydroxychloroquine sulfate gloup:Hydroxychloroquine sulfate 0.2g bid x 14 days a day
Chloroquine phosphate gloup:The first dose of chloroquine phosphate was 1gx2 days, and the third day was 0.5gx12 days
Control group:Recommended treatment plan for novel coronavirus pneumonia diagnosis and treatment plan
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. RT-PCR positive for 2019-nCoV or Confirmed lung involvement with chest imaging; 3. The clinical symptoms are slight, and there is no obvious manifestation of pneumonia (mild disease) or clinical symptoms such as fever and respiratory tract in imaging. The manifestation of pneumonia (common type) can be seen in imaging; 4. <=7 days since onset of the disease; 5. Willingness of study participant to accept randomization to any assigned treatment arm; 6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
Exclusion criteria
Exclusion criteria: 1. Investigator makes a decision that trial participation is not in patients' best interest, or any condition that does not allow the protocol to be followed safely; 2. As judged by investigator historic or current diseases that may have impact on the subjects participation of the study or the study outcome. These diseases include but not limited to cadiac diease and arrhythmia and QT prolongation), neurological disease psychiatric disease,active bleeding, serious malnutrition and endocrine disease; currently complicated with serious respiratory disease or that seriously affect immune system, such as flu, COPD, asthma, HIV infection, blood system disease, or splenectomy, organ transplantation etc.; 3. Severe liver disease (AST>3 ULN); 4. Patients with known severe renal impairment (estimated glomerular filtration rate <=60 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 5. QT elongation; 6. Allergic to chloroquine or hydroxychloroquine; 7. Pregnant or breastfeeding, or positive pregnancy test in a predose examination; 8. Will be transferred to another hospital within 72 hours; 9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 14 days prior to the time of the screening evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens;clinical status;Time from study entry to discharge;Frequency of serious adverse drug reactions;Dynamic changes of laboratory indexes;Dynamic changes of daily vital signs (body temperature, respiratory rate, blood pressure, heart rate); | — |
Countries
China
Contacts
Public ContactYin Zhenyu
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed