Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      Background:

      The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
      were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already
      converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild
      cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings:
      Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration
      of Study: From 1st May, 2020 to 30th June, 2020.Patients & Methods: Sample size and
      technique: Sample size was 50 patients; 25 patients were kept in control group and 25
      patients were kept in experimental group
    

Detailed description: 
      The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
      were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already
      converted into a global pandemic, having different forms of presentation in different
      patients.

      Exponential rise in its cases along with associated mortality has shaken the world.

      The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a single-stranded
      ribonucleic acid (RNA) virus that causes a severe acute respiratory syndrome. The virus was
      originally called SARS-CoV-2 named officially by World Health Organization as COVID-19 and a
      global health emergency. The first known case of infection was recorded in early December
      2019 and subsequently spread to various continents, including Europe and the United
      States.Generally, 75 percent of patients recover without any notable complication however 25
      percent can experience associated complications leading to intensive care unit transfer and
      even mortality.

      Ivermectin has different effects to treat variety of diseases and it has proven
      antimicrobial, antiviral, and anti-cancer properties and considered as a wonder drug. It is
      highly effective against many microorganisms including some viruses. Many studies revealed
      its antiviral effects on RNA viruses such as Zika, dengue, yellow fever, West Nile, Hendra,
      Newcastle, Venezuelan equine encephalitis, chikungunya, Semliki Forest, Sindbis, Avian
      influenza A, Porcine Reproductive and Respiratory Syndrome, Human immunodeficiency virus(HIV)
      type 1, and severe acute respiratory syndrome coronavirus SARS-CoV-2. Fon other hand there
      are few studies showing antiviral effects of ivermectin against DNA viruses such as Equine
      herpes type 1, BK polyomavirus, pseudorabies, porcine circovirus 2, and bovine herpesvirus
      1.5 Ivermectin plays a vital role in several biological mechanisms, therefore it could emerge
      as a potential candidate in the treatment of a wide range of viruses including COVID-19 as
      well as other types of positive-sense single-stranded RNA viruses. In vivo studies of animal
      models revealed a broad range of antiviral effects of ivermectin, however, more clinical
      trials are necessary as it's the need of the hour to do so, as we can validate the potential
      efficacy of ivermectin in clinical settings.

      The recent report by Caly et al.6 describing the antiviral potential of ivermectin against
      the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro arrive to the
      agenda of potential candidates for COVID-19 treatment.

      Currently, there is not any Food and drug administration (FDA) approved specific effective
      antiviral treatment available for COVID-19.Although most of the COVID-19 patients have mild
      or moderate courses, up to 5%-10% can have severe, potentially life threatening course, there
      is an urgent need for development of effective & safe drugs to deal with this novel virus.
      Optimized supportive care remains the mainstay of therapy. There are more than 300 clinical
      trials going on, various antiviral and immunomodulating agents are in different stages of
      evaluation for COVID-19 in those trials and results/ primary end points of few trials will be
      published in the next couple of months. Despite the urgent need to find an effective and safe
      antiviral treatment for COVID-19 through randomized controlled studies, certain agents are
      being used all over the world based on either in-vitro or conclusive evidence or
      observational studies.

      The clinical efficacy and utility of ivermectin in SARS-CoV-2-infected patients is
      unpredictable at this stage, as we are dealing with a completely novel virus.

      There is an urgent need for investigation of the mortality causes and development of novel
      therapeutic options for severe COVID-19.
    

Intervention name(s): Ivermectin
Intervention type(s): Drug
Intervention description(s): Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12 mg per oral stat and then 12 mg per oral after 12 hours and 12 mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.Any side effects of the drugs were noted as well
Other intervention name(s): Experimental
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Response of the patients after Ivermectin prescription and response of the patients without Ivermectin prescription was recorded. Response was recorded on the basis of clinical parameters (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. Any side effects noted after prescription of Ivermectin was recorded.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corona virus; SARS-COv-2; Ivermectin; pandemic; antiviral