Early-stage use of enoxaparin in COVID-19 improves clinical symptoms and reduces hospital stays

On January 17, 2022, Shenzhen Haipurui Pharmaceutical Group Co.
, Ltd.
(hereinafter referred to as "Hypurui") announced that the company's enoxaparin sodium preparation Inhixa participated in the preliminary results of a clinical trial INHIXACOVID19 in Italy
.
According to preliminary data of the study, timely use of enoxaparin at higher than preventive doses or moderate doses of new coronary pneumonia patients can shorten the hospital stay by 20% or more and relieve symptoms in more than 65% of cases
.
The trial is the first clinical trial using heparin in COVID-19 patients approved by the Italian Medicines Agency (AIFA) in 2020, and the only clinical trial completed so far
.
The figures were presented at the 20th SIMIT conference in Milan, and the full report will be published shortly
.
As an anticoagulant, enoxaparin sodium is one of the most commonly used prophylactic and therapeutic drugs for venous and arterial thromboembolism
.
With the outbreak of the new crown epidemic, changes in coagulation function and thrombosis are one of the important variables related to the mortality of new coronary pneumonia.
Therefore, the World Health Organization [1] In January 2020, it was recommended that heparin (preferred low molecular weight heparin) should be given.
) to prevent venous thromboembolism (VTE) in COVID-19 patients
.
In addition, early in the outbreak, in vitro tests had shown that the SARS-CoV-2 virus appeared to disappear after exposure to high concentrations of enoxaparin sodium
.
Therefore, Italian doctors have joined hands with Techdow Pharma Italy SRL, a subsidiary of Hepalink, to use Inhixa, which is widely recognized in Europe, as an experimental drug to evaluate the efficacy of enoxaparin administered at a new dose in improving the course of COVID-19 disease.
Safety and Efficacy
.
The trial was designed as a phase II single-arm interventional prospective study.
Each patient was followed up for at least 90 days after the diagnosis of COVID-19.
Patients enrolled in the interventional study were given daily doses of 45 to 60 kg, 61 to 100 kg, or body weight >100 kg, respectively.
A single subcutaneous injection of 60 mg, 80 mg, and 100 mg of enoxaparin for 14 days with dose adjustment based on monitoring of anti-factor Xa activity.
Patients enrolled in the observational cohort received a standard thromboprophylactic dose of enoxaparin subcutaneously 40 mg once daily13 Two Italian centers[2] participated in the trial and recruited more than 300 patients with moderate to severe COVID-19
.
Preliminary data showed that between enrollment and day 14, 64% of patients in the intervention cohort and 57.
8% of patients in the observational cohort observed an improvement in clinical status.
, the observational cohort was 11-22 days In addition, dose escalation of enoxaparin was safe with only 1 major bleeding event in the interventional cohort, with no major harm to patients following treatment
.
Pierluigi Viale, Professor of Infectious Diseases at the University of Bologna, Head of Infectious Diseases and Research Coordinator at the Santa Orsola-Malpigi Polyclinic, said: "The reduction in clinical course and length of hospital stay is an encouraging initial trial.
The results provide a basis for the subsequent extensive promotion of large-sample trials.
" Professor Zhai Zhenguo from the National Center for Respiratory Medicine, the Respiratory Center of China-Japan Hospital, and the Department of Respiratory and Critical Care Medicine commented on the study.
Scholars at home and abroad are concerned that in the clinical practice of fighting against the new coronary pneumonia epidemic, it is found that nearly 20% of the new coronary pneumonia patients will have abnormal coagulation function, and almost all severe and critical patients have obvious coagulation dysfunction.
New coronary pneumonia patients with VTE , especially combined with pulmonary embolism (PE), may be an important cause of disease aggravation and even death in infected patients.
In addition, some patients have obvious hypercoagulable state in the early stage.
If not intervened, extensive microthrombosis may be secondary to Disseminated intravascular coagulation (DIC), which seriously affects the prognosis of patients" To provide effective intervention strategies to help clinicians around the world treat patients with new coronary pneumonia and VTE risk, as early as the early 2020 epidemic, Professor Zhai Zhenguo's team and European experts jointly wrote The "Expert Consensus on Prevention and Treatment of New Coronary Pneumonia Complicated with VTE" is not only based on China's anti-epidemic practice experience and comprehensive literature search, but also provides clinicians with recommendations for the prevention and treatment of venous thromboembolism in patients with New Coronary Pneumonia, and for different serious diseases.
Provide detailed diagnosis and treatment advice for specific conditions such as degree, thrombosis risk, bleeding risk, etc.

.
Professor Zhai Zhenguo said: "The risk assessment and prevention of VTE is an important part of the comprehensive treatment of new coronary pneumonia.
Based on the current evidence-based medical evidence and clinical experience, it is recommended that low molecular weight heparin is the first choice for hospitalized patients with new coronary pneumonia who are at risk of concurrent VTE.
Treatment is very gratifying to see that the study on the application of Chinese enoxaparin in severe patients with new coronary pneumonia in Italy has achieved good results, and further recommendations on dosage application are given.
Shorten the hospital stay of patients by 20% or more, and relieve symptoms in more than 65% of cases.
However, clinicians need to pay attention to the repeated illness of some patients, and there may be major changes in the condition in the short term, which may lead to dynamic changes in the risk of thrombosis and bleeding during treatment.
Therefore, it is necessary to repeatedly evaluate and optimize treatment strategies to reduce the occurrence of deep vein thrombosis (DVT) and fatal PE, and to help patients recover quickly while ensuring patient safety.
” said Li Li, Chairman and President of Hepalink: “Enoxaparin Sodium It is a timeless and classic drug that no one expected when Tiandao Italy was established four years ago.
Today we come to explore its importance in the prevention of infectious complications associated with COVID-19.
The preliminary results of the INHIXACOVID19 trial are also available.
It shows that enoxaparin sodium still has a lot of potential to be tapped.
Hepalink is very gratified and honored to be able to play a small role in this epidemic that affects global health.
” [1] World Health Organization “Suspected Novel Coronavirus (2019 NCOV) Interim guidance on the clinical management of severe acute respiratory tract infection in the setting of infection"
.
[2] University Hospital of Sant'Orsola-Malpigi, Bologna, University Hospital of Parma, Hospital Vittorio Emmanuel Clinic, University of Catania, General University Hospital of Verona, University of San Carlo in Potenza Hospital, Cremona University Hospital, Brescia Civic Association Hospital, Brescia Polyan Blanca Foundation, San Giovanni Rotondo IRCCS Families for Suffering (FG), Milan San Rafael Scientific Research Hospital, Turin Amedio Savoy Hospital, Mantova Carlo Poma Hospital and Infectious Diseases Unit of the Province of Forli-Cesena in Rimini and Emilia-Romagna
.
About Inhixa's enoxaparin sodium formulations are sold in the Chinese market under the brand of Prozine®, sold in the EU non-Polish market under the brand of Inhixa, and sold in the Polish market under the brand of Neoparin.
Enoxaparin sodium preparations whose specifications (0.
2ml/0.
4ml/0.
6ml/0.
8ml/1.
0ml) have passed the consistency evaluation of generic drugs are the first generic drugs of enoxaparin sodium injection approved by the China Food and Drug Administration.
The first enoxaparin sodium injection biosimilar approved for sale by the European Medicines Agency has accumulated sales of more than 200 million in Europe.
Currently, the enoxaparin sodium preparations under Hepalink are sold in 43 countries and regions around the world
.