COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49263

Xia Jinyu

xiajinyu@mail.sysu.edu.cn

2020-02-11

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(All the following criteria are met before being selected): 1. Aged >= 18 years, 2. Meet all the following criteria (refer to confirmed cases in the 5th edition of the diagnosis and treatment plan): (1) Epidemiological history, (2) Clinical manifestations (according to any of the following 2): fever, normal or decreased white blood cell count or reduced lymphocyte count in the early stages of onset, multiple small patchy shadows and interstitial changes in early chest imaging, which are evident in the extrapulmonary zone. Furthermore, it develops multiple ground glass infiltration and infiltrates in both lungs. In severe cases, pulmonary consolidation and pleural effusion are rare. (3) Confirmed: Suspected cases have one of the following pathogenic evidence: respiratory specimens, blood specimens, or fecal specimens are detected by real-time fluorescent RT-PCR to detect novel coronavirus nucleic acid, the above-mentioned specimens are genetically sequenced and highly homologous to known new coronaviruses . (4) Light or ordinary patients, (5) With or without anti-viral drugs other than chloroquine phosphate, lopinavir/ritonavir.

(Subjects cannot enter the study if they meet any of the following conditions): 1. Patients with a history of allergy to chloroquine phosphate, lopinavir, and ritonavir, 2. Patients with hematological diseases, 3. Patients with chronic liver and kidney disease and reaching the end stage, 4. Patients with arrhythmia and chronic heart disease, 5. Patients known to have retinal disease, hearing loss or hearing loss, 6. Patients with known mental illness, 7. Patients who must use digitalis because of the original underlying disease, 8. Pancreatitis, 9. Hemophilia, 10. Broad bean disease, 11. Female patients during pregnancy.

2

The Fifth Affiliated Hospital Sun Yat-Sen University

18

None

China

No restriction on type of patients

0: No restriction on type of patients

112

Length of stay;Length of severe;oxygenation index during treatment;all-cause mortality in 28 days;Peripheral blood cell count (including white blood cells; lymphocytes; neutrophils; etc.);procalcitonin;C-reactive protein;Inflammatory factors (including IL-6; IL-10; TNF-a; etc.);Lymphocyte subsets and complement;Coagulation indicators (prothrombin time; activated partial prothrombin time; fibrinogen; D-dimer; platelet count);Virus nucleic acid;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]