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A randomized, parallel controlled open-label trial for the efficacy and safety of Prolongin (Enoxaparin Sodium Injection) in the treatment of adult patients with novel coronavirus pneumonia (COVID-19)

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)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030701
Enrollment
Unknown
Registered
2020-03-10
Start date
2020-03-10
Completion date
Unknown
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Sponsors

The Third People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Those who agree to take part in the test and sign the informed consent form voluntarily; 2. Adult 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) 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

Exclusion criteria: 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. Low body weight patients (females<45kg, males<57kg); 3. 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; 4. Have any situation that treatment with low molecular heparin is required; 5. 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; 6. 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; 7. 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; 8. Patients known to have severe renal impairment [creatinine clearance (CcCl) < 30 ml/min], or to receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis; 9. At rest without oxygen inhalation, SPO2 <=93%, or PaO2/ FiO2 <=300 mmHg; 10. Patients allergic to enoxaparin, heparin or its derivatives, including other low-molecular-weight heparins.

Design outcomes

Primary

MeasureTime frame
Time to Virus Eradication;

Secondary

MeasureTime frame
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 );

Countries

China

Contacts

Public ContactCai Qingxian

The Third People's Hospital of Shenzhen

41180423@qq.com+86 13760857996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026