COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50786

Zhang Yu

whxhzy@163.com

2020-03-10

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Those who agree to take part in the test and sign the informed consent form voluntarily, 2. Adults aged >=18years old, male or female, 3. The inpatients with mild or common type of COVID-19 confirmed according to the diagnostic criteria COVID-19 diagnosis and treatment plan - Sixth trial edition issued by the National Health Commission. 4. Respiratory Specimens (including but not limited to sputum, nasopharyngeal swab and secretion of lower respiratory tracts) are positive for 2019-nCoV nucleic acid by real-time fluorescent RT-PCR, or respiratory specimens are genetically sequenced and highly homologous to known 2019-nCoV.

1. Participation in the study is not in accordance with the rights and interests of the patient based on PIs judgement, or any other circumstances that investigators consider inappropriate for participation, 2. With bleeding or bleeding associated with severe coagulation disorders (except for disseminated intravascular coagulation unrelated to heparin therapy), with a history of severe type II heparin-induced thrombocytopenia, whether or not caused by unfractionated heparin or low-molecular-weight heparin (significantly reduced by platelet count previously), active peptic ulcer or organ damage with bleeding tendency, clinically significant active bleeding , cerebral hemorrhage, 3. Have any situation that treatment with low molecular heparin is required, 4. Females who are pregnant or likely to be pregnant, or who are lactating and unable to stop breastfeeding, or who have positive pregnancy tests during screening, 5. Males or females who have a birth plan or are unwilling to take reliable contraceptive measures for contraception within 90 days from signing the informed consent to the last dose, 6. With severe liver disease: patient with basic diseases of liver cirrhosis , or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) increased more than 5 times of the normal upper limit, 7. Patients known to have severe renal impairment [creatinine clearance (CcCl) < 30 ml / min], or to receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis, 8. At rest without oxygen inhalation, SPO2 <=93%, or PaO2/ FiO2 <=300 mmHg, 9. Patients allergic to enoxaparin, heparin or its derivatives, including other low-molecular-weight heparins.

2

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

18

None

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

Time to Virus Eradication;

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

Phase 0

[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]