COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49524

Guochao Shi

shi_guochao2010@qq.com

2020-02-15

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Aged 18 years old and above, 2. Meet the novel coronavirus pneumonia (COVID-19) diagnostic criteria. The upper and lower respiratory tract RT-PCR confirmed that 2019-nCoV nucleic acid positive, chest CT imaging examination could be used in conjunction, 3. SaO2/SpO2=94% under indoor air, or PaO2/FiO2<300mgHg (for severe type patients), 4. Sign informed consent, 5. Do not participate in the clinical study of other study drugs within 28 days.

1. Aged less than 18 years old, 2. Other serious medical diseases such as malignant tumor, heart, liver and kidney disease, uncontrollable metabolic disease, etc, 3. Not suitable for gastrointestinal administration, 4. Pregnant or lactating women, 5. Those who are allergic to the ingredients of this product, 6. Mental state can not cooperate with the observer or cognitive impairment, 7. Severe liver disease (such as child Pugh score >=C, AST > 5 times ULN), 8. Patients with known severe renal impairment (creatinine clearance rate <=30 ml/min) or continuous renal replacement therapy, hemodialysis, peritoneal dialysis.

2

Ruijin Hospital; Shanghai Jiaotong University School of Medicine

18

None

China

No restriction on type of patients

0: No restriction on type of patients

360

Viral nucleic acid test;

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

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]