Efficacy of Ivermectin in COVID-19
Condition: Safety; SARS-CoV2 Infection; Ivermectin Poisoning; Effect of Drug
MeSH terms: Infections; COVID-19; Poisoning
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The newly emerged corona virus disease 2019 (COVID-19) has spread to all over the world, with
      recent estimates of more than 236 million cases diagnosed and led to 4.8 million deaths as
      November 20211 .Therapeutic approaches are needed to improve outcomes in patients with
      COVID-19 since no antiviral agent has yet been proved to be conclusively beneficial in
      COVID-19 infection,especially in patients with mild to moderate degree of severity There has
      been growing interest in the anti-parasitic drug,ivermectin, which previously was studied as
      an antiviral, anti-inflammatory and anti-cancer actions2 .It was also reported to have an
      in-vitro activity against SARS-CoV-23 .Its antiviral properties was due to the action on
      importin 2/1 mediated nuclear transport. Ivermectin prevents the binding of viral proteins to
      importin 2/1 rendering the viral proteins unable to enter the nucleus and cause infection4.

      Several clinical studies have found a beneficial effect of ivermectin in COVID-195-9 However,
      some study did not find significant difference between the patient group receiving ivermectin
      and control group10 .Until now, the controlled trials evaluating ivermectin in COVID-19 are
      lacking. Ivermectin is safe, with reported side effect of less than 1%. Hence it is essential
      to conduct a clinical trial with ivermectin in patients with COVID-19 .The objective of this
      study is to establish the efficacy of ivermectin for COVID-19 patients with mild to moderate
      disease, compare to usual case alone.
    

Detailed description: 
      This study is a randomized, double-blind, placebo controlled trial conducted at Faculty of
      Medicine, Vajira Hospital, Navamindradhiraj University from September 2021 to the end of
      November 2021.

      The patients were randomized in permuted block of four in a randomized sequence prepared by
      the unblinded pharmacist in Microsoft excel12 .Allocation assignment was concealed from
      investigators and the patients. The patients were allocated into two groups : either to group
      A (Ivermectin arm) or to group B (control arm) as shown in Fig 1. The patients were
      randomized in a 1:1 ratio .Group A received ivermectin 12 mg per day for 5 days as
      recommended by previous studes13,14 plus standard care. Group B was to receive standard care
      alone which included favipiravir or andrographolide, corticosteroids, cetrizine and
      paracetamol.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ivermectin plus standard care; Standard care
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: a randomized ,double blind,placebo,controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: efficacy; ivermectin; covid-19; randomised controlled trial