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Trial - ChiCTR2000029899


Column Value
Trial registration number ChiCTR2000029899
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Shen Ning

Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

shenning1972@126.com

Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-02-16

Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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, 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.

Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Peking University Third Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

None

Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

China

Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Time to Clinical Recovery; TTCR;

Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"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"}]