ChiCTR2000030700.

Study name	An evaluative clinical study: efficacy and safety of Prolongin (enoxaparin sodium injection) in treatment of hospitalized adult patients with common novel coronavirus pneumonia (COVID‐19)
Starting date	09 March 2020
Contact information	Zhang Yu Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China +86 13901849660 | whxhzy@163.com
Methods	Prospective RCT; open label, 1:1; 2‐armed, parallel‐assignment study
Participants	60 participants, ≥ 18 years, female and male Inclusion criteria Those who agree to take part in the test and sign the informed consent form voluntarily Adults aged ≥ 18 years, male or female 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 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. Exclusion criteria Participation in the study is not in accordance with the rights and interests of the patient based on Principal Investigator's judgement, or any other circumstances that investigators consider inappropriate for participation 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 HIT, whether or not caused by UFH or LMWH (significantly reduced by platelet count previously), active peptic ulcer or organ damage with bleeding tendency, clinically significant active bleeding, cerebral haemorrhage Have any situation that treatment with LMWH is required; Women 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 Men or women who have a birth plan or are unwilling to take reliable contraceptive measures for contraception within 90 d from signing the informed consent to the last dose With severe liver disease: patient with basic diseases of liver cirrhosis, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) increased > 5 times of the ULN Patients known to have severe renal impairment (creatinine clearance (CcCl) < 30 mL/min), or to receive continuous renal replacement therapy, haemodialysis or peritoneal dialysis At rest without oxygen inhalation, SPO2 ≤ 93%, or PaO2/FiO2 ≤ 300 mmHg Patients allergic to enoxaparin, heparin or its derivatives, including other LMWHs
Interventions	Experimental: based on the standard treatment recommended in the guidelines, a combination of Prolongin (enoxaparin sodium injection) was used Comparator: follow the guidelines for standard treatment
Outcomes	Primary Time to virus eradication Secondary The incidence of mild or common novel coronavirus pneumonia progressing to severe Time for the main clinical manifestations to subside (fever, cough, respiratory rate, SPO2)
Notes	ChiCTR2000030700 | No data provided