Monotherapy versus polytherapy of enoxaparin and hydroxychloroquine for the treatment of COVID-19: A randomized controlled clinical trial

Main Article Content

Amira S.A. Said https://orcid.org/0000-0002-6341-3553
Raghda R S Hussein https://orcid.org/0000-0002-0503-685X
Doaa Mahmoud Khalil https://orcid.org/0000-0002-9003-0136
Alzhraa M Fahmy https://orcid.org/0000-0001-7243-3006
Ahmed H A Hassanein https://orcid.org/0000-0001-9906-0721
Lamiaa N Abdelaty https://orcid.org/0000-0003-0061-4435

Keywords

COVID-19 infection, Enoxaparin, Hydroxychloroquine, ICU stay, Length of hospital stay, Mortality

Abstract

Objectives: The current study aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine (HCQ) used as monothrapy or polytherapy versus standard care alone in Coronavirus 2019 (COVID-19) infected patients. Methods: The current study included two hundred patients with laboratory confirmed COVID-19 infection. Patients admitted to hospital were randomly allocated into four groups: group I: received standard COVID-19 therapy, group II: received Enoxaparin 40mg/day subcutaneously (SC) plus standard therapy, group III: received 400 mg/day HCQ plus standard therapy & group IV: received a combination of 400 mg/day HCQ and Enoxaparin plus standard COVID-19 therapy. The disease progression was evaluated by duration to a negative polymerase chain reaction (PCR), length of hospital or Intensive Care Unit (ICU) stay, and mortality rate. The safety of treatments was evaluated by measuring adverse effects. Results: The length of hospital stay, ICU admission and mortality were significantly decreased in Enoxaparin plus standard COVID-19 therapy group versus other groups. Conclusion: These findings suggest that Enoxaparin was safe, effective, and well tolerated and has a role in decreasing the progression of the disease and its complications while HCQ did not discover any evidence of extra therapeutic benefits

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References

1. Pawlowski C, Venkatakrishnan AJ, Kirkup C, et al. Enoxaparin is associated with lower rates of mortality than unfractionated Heparin in hospitalized COVID-19 patients. Clinical Medicine. 2021;33:100774. https://doi.org/10.1016/j.eclinm.2021.100774
2. Lewis K, Chaudhuri D, Alshamsi F, et al. The efficacy and safety of hydroxychloroquine for COVID-19 prophylaxis: A systematic review and meta-analysis of randomized trials. PLoS One. 2021;16(1):1-16. http://dx.doi.org/10.1371/journal.pone.0244778
3. Al-Bari MAA. Targeting endosomal acidification by chloroquine analogs as a promising strategy for the treatment of emerging viral diseases. Pharmacol Res Perspect. 2017;5(1):1-13. https://doi.org/10.1002/prp2.293
4. Zhou D, Dai SM, Tong Q. COVID-19: A recommendation to examine the effect of hydroxychloroquine in preventing infection and progression. J Antimicrob Chemother. 2020;75(7):1667-70. https://doi.org/10.1093/jac/dkaa114
5. Billett HH, Reyes-Gil M, Szymanski J, et al. Anticoagulation in COVID-19: Effect of Enoxaparin, Heparin, and Apixaban on Mortality. Thromb Haemost. 2020;120(12):1691-9. https://doi.org/10.1093/jac/dkaa114
6. Zhang R, Ni L, Di X, et al. Systematic review and meta-analysis of the prevalence of venous thromboembolic events in novel coronavirus disease-2019 patients. J Vasc Surg Venous Lymphat Disord. 2021;9(2):289-298.e5. https://doi.org/10.1016/j.
jvsv.2020.11.023
7. Cuker A, Tseng EK, Nieuwlaat R, et al. American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on postdischarge thromboprophylaxis. Blood Adv.
2022;6(2):664-71. https://doi.org/10.1182/bloodadvances.2021005945
8. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost.
2020;18(8):1859-65. https://doi.org/10.1111/jth.14929
9. Gilat R, Haunschild ED, Tauro T, et al. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. Ann Oncol. 2020;(1):19-21.
10. Connors JM, Levy JH. COVID-19 and its implications for thrombosis and anticoagulation. Blood. 2020;135(23):2033-40. http://dx.doi.org/10.1182/blood.2020006000
11. Rentsch CT, Beckman JA, Tomlinson L, et al. Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: Cohort study. BMJ. 2021;372. https://doi.org/10.1136/
bmj.n311
12. Tang N, Bai H, Chen X, et al. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020;18(5):1094-9. https://doi.org/10.1111/jth.14817
13. Vaughn VM, Yost M, Abshire C, et al. Trends in Venous Thromboembolism Anticoagulation in Patients Hospitalized with COVID-19. JAMA Netw Open. 2021;4(6):1-13. https://doi.org/10.1001/jamanetworkopen.2021.11788
14. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, Bleeding, Mortality, and Pathology in Hospitalized Patients with COVID-19. J Am Coll Cardiol. 2020;76(16):1-13.
15. Pesavento R, Ceccato D, Pasquetto G, et al. The hazard of (sub)therapeutic doses of anticoagulants in non-critically ill patients with Covid-19: The Padua province experience. J Thromb Haemost. 2020;18(10):2629-35. https://doi.org/10.1111/jth.15022
16. Drago F, Gozzo L, Li L, et al. Use of Enoxaparin to Counteract COVID-19 Infection and Reduce Thromboembolic Venous  Complications: A Review of the Current Evidence. Front Pharmacol. 2020;11(3):1-6. https://doi.org/10.3389/fphar.2020.579886 
17. Albani F, Sepe L, Fusina F, et al. Thromboprophylaxis with Enoxaparin is associated with a lower death rate in patients hospitalized with SARS-CoV-2 infection. A cohort study. Clinical Medicine. 2020;27(2):5. https://doi.org/10.1016/j.eclinm.2020.100562
18. Shastri MD, Stewart N, Horne J, et al. In-vitro suppression of IL-6 and IL-8 release from human pulmonary epithelial cells by non-anticoagulant fraction of Enoxaparin. PLoS One. 2015;10(5):1-23. https://doi.org/10.1371/journal.pone.0126763
19. Shi C, Wang C, Wang H, et al. Clinical observations of low molecular weight heparin in relieving inflammation in COVID-19 patients: A retrospective cohort study. medRxiv. 2020;2020.03.28.20046144. https://doi.org/10.21203/rs.3.rs-154472/v1
20. Udwadia ZF, Malu KN, Rana D, et al. Hydroxychloroquine for COVID-19: What is our Current State of Knowledge? J Assoc Physicians India. 2020;68(6):48-52.
21. Abd-Elsalam S, Esmail ES, Khalaf M, et al. Hydroxychloroquine in the treatment of COVID-19: A multicenter randomized controlled study. Am J Trop Med Hyg. 2020;103(4):1635-9.
22. Sarma P, Kaur H, Kumar H, et al. Virological and clinical cure in COVID-19 patients treated with hydroxychloroquine: A systematic review and meta-analysis. J Med Virol. 2020;92(7):776-85. https://doi.org/10.1002/jmv.25898
23. Horby PW, Mafham M, Linsell L, et al. Effect of hydroxychloroquine in hospitalized patients with COVID-19: Preliminary results from a multi-centre, randomized, controlled trial. medRxiv. 2020. https://doi.org/10.1101/2020.07.15.20151852
24. Tang W, Cao Z, Han M, et al. Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial. 2020;2019-20.
25. Self WH, Semler MW, Leither LM, et al. Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients with COVID-19: A Randomized Clinical Trial. JAMA - J Am Med Assoc. 2020;324(21):2165-76.
26. Johnston C, Brown ER, Stewart J, et al. Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial. Clinical Medicine. 2021;33(2):100773. https://doi.
org/10.1016/j.eclinm.2021.100773

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