Safety and Efficacy of Enoxaparin and Hydroxychloroquine in COVID-19
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      In this randomized controlled study, two hundred patients with positive PCR and laboratory
      confirmed COVID-19 will be classified randomly into four groups. The first group is the
      control group and will be given the conventional treatment of covid-19 only. The second group
      will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be
      given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of
      covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus
      the conventional therapy of covid-19

      The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment
      and length of hospital stay. The safety will be assessed by measuring the severity of side
      effects by following up the patients after treatment.
    

Detailed description: 
      Although numerous therapeutic agents for COVID-19 are under investigation, an effective
      therapy remains a challenge among researchers. To date, hydroxychloroquine has been widely
      used for covid-19 treatment, despite that its efficacy and safety need further
      investigations. Coagulopathies are major complications of covid-19 infection, hence
      prophylactic anticoagulation has been recommended in all hospitalized patients. This study
      aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine used separately
      or combined and added to standard care versus standard care alone in Covid-19 infected
      patients. An observational study including two hundred patients (98 males, 102 females) with
      laboratory confirmed covid-19 infection was conducted. Patients admitted to hospital were
      randomly allocated into four equal treatment groups. The first group received standard
      Covid-19 therapy, second group received enoxaparin 40mg/day SC for 14 days plus standard
      Covid-19 therapy, third group received 400 mg/day HCQ for five days plus standard Covid-19
      therapy. The fourth group received a combination of 400 mg/day HCQ and enoxaparin plus
      standard Covid-19 therapy. The clinical disease course progression was evaluated by duration
      to a negative PCR, length of hospital or ICU stay, and mortality rate. The safety of
      treatments was evaluated by measuring liver biochemistries (ALT, AST), random blood glucose
      levels and adverse effects during the 28 days of treatment. Patients on Enoxaparin plus
      standard Covid-19 therapy significantly showed a decrease in length of hospital stay, ICU
      admission and mortality compared to all other treatments. However, the duration to both
      negative PCR and clinical improvement did not find any significance. These findings suggest
      that enoxaparin treatment 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 over other treatments.
    

Intervention name(s): Enoxaparin, Hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): To compare efficiency and safety of Enoxaparin and Hydroxychloroquine as monotherapy versus Polytherapy
Intervention MeSH terms: Hydroxychloroquine; Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Patients were randomized into four parallel equal groups using a computerized random number generator using simple randomization with an equal allocation ratio. Two hundred and twenty patients were eligible. Twenty patients were excluded due to not meeting the inclusion criteria (n=14) or the decline to be enrolled in the study (n=4). The sample size was calculated by G.power version 3.1 for windows (Faul et al., 2009). With a priori calculating the sample size based on the length of stay among the studied groups using one way ANOVA test (F-test group), at an effect size (0.306), alpha probability (0.05) and power (95%), the calculated sample size was 184 in the 4 groups that increased to 200 (with 6% increase) to overcome the missing of data and dropout or loss of follow up.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19 infection; Enoxaparin; Hydroxychloroquine; ICU stay