COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=48991

Jianping Zhao

zhaojp@tjh.tjmu.edu.cn

2020-02-03

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Adult aged >= 18 years old, 2. Patients with unexplained viral pneumonia that have been clinically diagnosed or patients with novel coronavirus serum antibody (IgM or IgG) positive or patients with novel coronavirus infection confirmed by PCR when no rapid diagnostic kit has been developed, 3. The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used,

1) Any situation that makes the programme cannot proceed safely, 2) patients who have used Kaletra or remdesivir, 3) no clinical or chest imaging manifestations, 4) In the state of no oxygen at rest, the patient's SPO2 <= 94% or the oxygenation index is less than 300mmHg respiratory rate >= 24/min, 5) Patients who need to be admitted to ICU judged by clinicians, 6) Known allergy or hypersensitivity reaction to lopinavir / ritonavir, 7) Increase in alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is more than 3 times the upper limit of normal, 8) Drugs that are forbidden to be treated with lopinavir / ritonavir and cannot be replaced or stopped during the study period, such as afzosin, amiodarone, fusidic acid, astemizole, terfenadine, piperazine, dihydroergomethane, ergometrine Alkali, ergotamine, methylergometrine, cisapride, lovastatin, simvastatin, sildenafil, vartanafi, midazolam, triazolam, St. John's wort (Hypericum perforatum extract), etc., 9) Pregnancy: positive pregnancy test for women of childbearing age, 10) lactating women did not stop lactation, 11) Known HIV infection, because of concerns about the development of resistance to lopinavir/rionavir if used without combination with other anti-HIV drugs, 12) Patient likely to be transferred to a non-participating hospital within 72 hours.

2

Tongji Hospital; Tongji Medical College; Huazhong University of Science and Technology

18

None

China

Mild disease at enrollment

1: Mild disease at enrollment

328

The incidence of adverse outcome within 14 days after admission: Patients with conscious dyspnea; SpO2 = 94% or respiratory frequency = 24 times / min in the state of resting without oxygen inhalation;

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

Phase 0

[{"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"}]