Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
phosphate chloroquine:Day 1-3:500mg BID
Day 4-5:250mg BID
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 Yearsmale or female subjects 2. Diagnosed with COVID-19,according to "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (Pilot Sixth Edition); 3. Sever COVID-19, except shock and ICU care with organ failure; 4. Antimalarial drugs such as chloroquine and hydroxychloroquine sulfate were not used within 3 months.; 5. Agreed not to participate in other clinical trials in the period of 30 days from first dose; 6. Eligible subjects (male and female) agree to use effective birth-control method (hormone or barrier or abstinence) during the trial and at least 3 month after the last dose; 7. Willingness of participant the study with inform consent form
Exclusion criteria
Exclusion criteria: 1 Patients with identified allergies to 4-aminoquinoline and lopinavir/litonavir; 2 Patients with server diseases of the blood system; 3 Patients with identified severe liver disease, underlying cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation more than 3 times the normal upper limit; 4 Patients with alcoholism or are taking hepatotoxic drugs; 5 Patients with renal impairment (estimated glomerular filtration rate [eGFR]< 30 mL/min/1.73m2, using the MDRD method); 6 Patients with 6-phosphate dehydrogenase deficiency; 7 History of acute myocardial infarction, unstable angina pectoris, severe arrhythmia (frequent ventricular, ventricular tachycardia, ventricular fibrillation) in recent 6 months; New York Heart Association (NYHA) level ?-?; 8 QTc=480ms 9 uncorrected patients with hypokalemia or hypokalemia 10Patients with retinopathy, fundus lesions, macular degeneration; 11 Patients with psychiatric disorders; 12? Patients with pancreatitis; 13? Patients with server auditory damage; 14? Pregnant or breastfeeding women or female with positive pregnancy test at child-bearing age; 15? Patients with medication that affect drug absorption, metabolism and excretion, that can induce QT interval prolongation, or drugs that can increase adverse reactions, etc.; 16? Patients were not eligible for this trial based on Investigator's considerationsPatients with a history of malignant tumor in the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTCI (Time to Clinical Improvement); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with 6-grades rating form at fixed time points (days 7, 14, 21, and 28 after randomization);All-cause mortality of 28-days;Duration of mechanical ventilation (days) of 28-days;Duration of supplemental oxygenation (days);Length of hospital stay (days);Transition time of 2019-nCoV nucleic acid detection; | — |
Countries
China
Contacts
Public ContactShen Ning
Peking University Third Hospital
Outcome results
None listed