Monotherapy versus polytherapy of enoxaparin and hydroxychloroquine for the treatment of COVID-19: A randomized controlled clinical trial
Amira S A Said, Doaa Raghda R S Hussein, Mahmoud Khalil, MD Alzhraa M Fahmy, PhD. Phd of Biotechnology, Ahmed H A Hassanein, Lamiaa N Abdelaty, Mahmoud Doaa, MD Khalil
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.
AUTHOR CONTRIBUTIONS Conceptualization: Amira S.A. Said, Lamiaa N Abdelaty, Alzhraa M. Fahmy, Raghda R.S. Hussein, Ahmed H.A. Hassanein. Data curation: Lamiaa N Abdelaty, Raghda R.S. Hussein., Formal Analysis: Doaa Mahmoud Khalil, Investigation: All authors,Project Administration: All authors, Methodology: Amira S.A. Said, Lamiaa N Abdelaty, Alzhraa M. Fahmy, Raghda R.S. Hussein, Ahmed H.A. Hassanein., Software: Doaa Mahmoud Khalil. Validation: Doaa Mahmoud Khalil., Resources: All Authors. Writing-original draft preparation: All Authors. Writing-review and editing: All Authors. Visualization: All Authors. Project administration: All Authors. Funding acquisition: non, authors have read and agreed to the published version of the manuscript.
FUNDING This research received no external funding.
INSTITUTIONAL REVIEW BOARD STATEMENT The study was conducted in accordance with the Declaration of Helsinki and in accordance with the guidelines of Good Clinical Practice and was approved by the Research Ethics Committee with serial number: REC-H-PhBSU-21013. Also, the study was
INFORMED CONSENT STATEMENT Written informed consent has been obtained from patients.
CONFLICTS OF INTEREST The authors declare no conflicts of interest.
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