COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=51693

Xiao Fei

xiaof35@sysu.edu.cn

2020-04-01

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Aged 18 to 75 years old, 2. mild or normal patients, 3. not using chloroquine phosphate, lopinavir other than other antiviral drugs, 4. under the gastroscope, there was mucosal damage and pathological biopsy of 2019-ncov nucleic acid positive, 5. confirmed cases meeting all the following criteria (the 5th edition of the medical guidelines): (1) epidemiological history, (2) Clinical manifestations (in accordance with any 2 of the following): fever, In the early stage of the disease, the total number of white blood cells was normal or decreased, or the lymphocyte count was decreased. In the early stage of chest imaging, multiple small plaques and stromal changes were observed, especially in the lung. Then, it developed into multiple ground-glass shadows and infiltrating shadows in both lungs. In severe cases, lung consolidation may occur, and pleural effusion is rare, (3) Confirmed: the suspected case has one of the following etiological evidence: respiratory or blood specimens were tested positive for novel coronavirus nucleic acid by real-time fluorescent rt-pcr, Respiratory or blood specimen virus gene sequencing, and known novel coronavirus highly homologous.

1. in pregnancy, breast-feeding female patients, 2. to determine the history of chloroquine phosphate, rabeprazole drug allergy patients, Patients suffering from diseases of the blood system, 3. patients suffering from chronic liver and kidney diseases and reaching the terminal stage, 4. Serious heart, lung dysfunction and mental illness, 5. Patients with known retinal diseases, hearing loss or hearing loss, 6. Patients who have to take digitalis drugs for existing underlying diseases, 7. Merger of other digestive tract diseases, 8. Combine ribavirin, 9. Involved in other processing clinical drug trials.

2

Infection prevention and treatment center of The Fifth Affiliated Hospital of Sun Yat-Sen University

18

75

China

Mild disease at enrollment

1: Mild disease at enrollment

56

2019-ncov nucleic acid yin rate;Blood 2019-ncov nucleic acid positive;Positive 2019-ncov nucleic acid in feces;Nasopharyngeal swab positive for 2019-ncov nucleic acid;

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

Phase 0

[{"arm_notes": "", "treatment_id": 1463, "treatment_name": "Chloroquine+rabeprazole", "treatment_type": "Antimalarials+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1603, "treatment_name": "Lopinavir+rabeprazole", "treatment_type": "Antivirals+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]