COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=48684

Zhang Dingyu

1813886398@qq.com

2020-01-23

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Adult aged >=18years old, 2. Patients infected with new coronavirus confirmed by PCR 3. In the state of no oxygen at rest, the patient's SPO2<=94% or the oxygenation index is less than 300mmHg.

1. Any situation that makes the programme cannot proceed safely, 2. Known allergy or hypersensitivity reaction to lopinavir / ritonavir, 3. Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 5 times the upper limit of normal, 4. Use of medications that are contraindicated with lopinavir / ritonavir and that cannot be replaced or stopped during the study period, such as CYP3A inhibitors, 5. Pregnancy: positive pregnancy test for women of childbearing age, 6. Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs, 7. Patient likely to be transferred to a non-participating hospital within 72 hours, 8. Researchers consider unsuitable.

2

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)

18

None

China

Severe disease at enrollment

6: Severe disease at enrollment

160

Clinical improvement time of 28 days after randomization;The 7-point scale;7 points: death;6 points: admission to ECMO and / or mechanical ventilation;5 points: Hospitalized for non-invasive ventilation and / or high-flow oxygen therapy;4 points: hospitalization for oxygen therapy;3 points: Hospitalization does not require oxygen therapy;2 points: discharged but not restored to normal functional status;1 point: discharged to normal function;

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

Not reported

[{"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]