ChiCTR2000030701.

Study name	A randomized, parallel controlled open‐label trial to evaluate the efficacy and safety of Prolongin (enoxaparin sodium injection) in adult hospitalized patients with novel coronavirus pneumonia (COVID‐19)
Starting date	10 March 2020
Contact information	Cai Qingxian The Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China +86 13901849660 | 41180423@qq.com
Methods	Single‐centre, open‐label, 2‐armed, parallel assignment RCT
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 Adult aged ≥ 18 years old, 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) were positive for 2019‐nCoV nucleic acid by real‐time fluorescent RT‐PCR; or respiratory specimens were 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 Low body‐weight patients (female < 45 kg, male < 57 kg) 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 days from signing the informed consent to the last dose With severe liver disease: patient with basic diseases of liver cirrhosis, or ALT)/AST increased > 5 times of the ULN Patients known to have severe renal impairment CrCl < 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 Comparison: 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	ChiCTR2000030701 | No data provided