Medical Journal of the Islamic Republic Of Iran

en Comparing Therapeutic versus Prophylactic Enoxaparin Therapy in Severe COVID-19 Patients: A Randomized Clinical Trial Infectious Disease Infectious Disease Original Research Original Research Background: Coronavirus disease 2019 (COVID-19) has been associated with a hypercoagulopathy state; however, the efficacy of different anticoagulant regimens in preventing thrombotic events is not clear. We aimed to compare therapeutic versus prophylactic enoxaparin therapy in severe COVID-19 patients.    Methods: In this single-center, open-label, randomized controlled trial, adult patients with severe COVID-19 presentations and an increased D-dimer level of more than 4 times the normal upper limit were randomly assigned to receive either prophylactic or therapeutic dose of enoxaparin. All patients were observed for at least 4 months regarding the overall survival as the primary outcome. Hospitalization duration, the need for intensive care unit (ICU) admission, the need for mechanical ventilation, and major adverse events (MAEs) were also analyzed as the secondary outcomes. Survival analysis was done via Kaplan-Meier curves and the Log-rank test. Cox regression was used, adjusting for baseline variables.    Results: Overall, 237 patients (152 men and 85 women) were randomized to either arm (121 to prophylactic and 116 to therapeutic groups). The mortality rate was 27 (22.3%) and 52 (44.8%) in prophylactic and therapeutic arms, respectively. Prophylactic enoxaparin was associated with better survival in the log-rank test (P < 0.001; HR, 0.42). Additionally, a significantly lower rate of ICU admission, a lower rate of MAEs, and shorter hospitalization were observed in the prophylactic arm (P < 0.001, P = 0.009, and P = 0.028, respectively).    Conclusion: The results of the current study were in favor of anticoagulant treatment with prophylactic doses of enoxaparin. Still, due to the limitations of this paper, we suggest that these findings be treated cautiously.   COVID-19, Enoxaparin, Survival 1008 1013 http://mjiri.iums.ac.ir/browse.php?a_code=A-10-5732-2&slc_lang=en&sid=1 Samira Kafan Kafan.samira@gmail.com 200319475328460080943 200319475328460080943 No Department of Internal Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Mohammad Reza Fattahi mr-fattahi@alumnus.tums.ac.ir, mrfattahi@sbmu.ac.ir 200319475328460080944 200319475328460080944 Yes Department of Internal Medicine, Sina Hospital, Tehran University of Medical Sciences, & Student Research Committee, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, & School of Medicine, Tehran University of Medical Sciences, Tehran, Iran Mahsa Akhbari Shojaie mahsa_shojaei86@yahoo.com 200319475328460080945 200319475328460080945 No Department of Internal Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Aida Hossein Nezhad aida.hosseinnezhad93@gmail.com 200319475328460080946 0009-0003-1067-6362 No School of Medicine, Islamic Azad University, Tonekabon Medical Branch, Tonekabon, Iran Mahshid Imankhan Mahshidimankhanmd@gmail.com 200319475328460080947 200319475328460080947 No School of Medicine, Islamic Azad University, Tehran Medical Branch, Tehran, Iran Davoud Jahansouz d-jahansouz@alumnus.tums.ac.ir 200319475328460080948 200319475328460080948 No Health Research Institute, Babol University of Medical Sciences, Babol, Iran Mahnaz Montazeri mmontazeri@sina.tums.ac.ir 200319475328460080949 200319475328460080949 No Department of Infectious Disease, Tehran University of Medical Sciences, Tehran, Iran Azar Hadadi hadadiaz@tums.ac.ir 200319475328460080950 200319475328460080950 No Department of Internal Medicine, Sina Hospital, & Department of Infectious Disease, Tehran University of Medical Sciences, Tehran, Iran Sara Fattahi sarafth81@gmail.com 200319475328460080951 0009-0004-7362-5455 No Department of Clinical Psychology, Tehran University of Medical Sciences, Tehran, Iran Arad Iranmehr Arad.iranmehr@gmail.com 200319475328460080952 200319475328460080952 No Neurosurgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Marzieh Pazoki asapazoki@gmail.com 200319475328460080953 200319475328460080953 No Department of Internal Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran Hormat Rahimzadeh r-rahimzadeh@sina.tums.ac.ir 200319475328460080954 200319475328460080954 No Department of Nephrology Disease, Tehran University of Medical Sciences, Tehran, Iran