COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49482

Shen Ning

shenning1972@126.com

2020-02-16

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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.

2

Peking University Third Hospital

18

75

China

Severe disease at enrollment

6: Severe disease at enrollment

100

TTCI (Time to Clinical Improvement);

| Declared number of arm (5.0) differs from found arms (6.0)

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]