Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
phosphate chloroquine:Day1-3:500mg,BID Day4-5:250mg,BID
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years at time of signing Informed Consent Form; 2. Patients with confirmed cases meeting the following criteria (1) Epidemiology history; (2) Clinical manifestations (epidemiological history and in accordance with any of the following 2 items; no clear epidemiology history, conforms to 3 items in clinical manifestations): Fever and / or respiratory symptoms; In the early stage of the disease, the total leukocyte count was normal or decreased, or the lymphocyte count decreased; Early chest imaging showed multiple small plaques and interstitial changes, which were evident in the extraneous lung. Further, multiple ground-glass shadows and infiltration shadows were found in both lungs, and lung consolidation and pleural effusion were rare in severe cases; (3) Having one of the following etiological evidence: Respiratory tract, blood or fecal samples RT-PCR confirmed infection with 2019-nCoV; The virus genes of the above samples were sequenced and highly homologous to the 2019-nCoV; 3. Patients who meet the following mild and normal criteria; Mild: mild clinical symptoms, no signs of pneumonia on imaging; Normal: fever, respiratory symptoms, imaging manifestations of pneumonia; 4. Antimalarial drugs such as chloroquine and hydroxychloroquine were not used within 3 months; 5. Agree not to participate in other clinical researchers within 30 days from the first administration of the study drug to the last administration; 6. Eligible fertile subjects (male and female) must agree to use effective birth control (hormone or barrier or abstinence) with their partner during the trial period and for at least 3 months after the last dose; 7. Patients who agree to participate in this study and are willing to sign the informed consent form voluntarily.
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]= 480ms; 9. Uncorrected patients with hypokalemia or hypokalemia; 10. Patients 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 |
|---|---|
| Time to Clinical Recovery, TTCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality of 28-days;Transition time of 2019-nCoV nucleic acid detection;Frequency of respiratory progression:Defined as SPO2= 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support;Time to defervescence (days);Time to cough reported as mild or absen t(days);Time to dyspnea reported as mild or absent (days);Time to requirement for supplemental oxygen or non-invasive ventilation (days); | — |
Countries
China
Contacts
Public ContactShen Ning
Peking University Third Hospital
Outcome results
None listed