Ivermectin Reproposing for Mild Stage COVID-19 Outpatients
Condition: Covid19; SARS (Severe Acute Respiratory Syndrome)
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      The emergency of COVID-19, along with the current difficulties in responding to the high
      demand for vaccines, requests to the scientific community to find alternative treatments
      based on reuse of drugs as a strategy to prevent the progression of the disease in patients
      infected with SARS COV 2.

      Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase
      outpatient discharge and prevent the progression to moderate or severe stages of the disease.

      Added value of this study We found that an intervention with ivermectin has impacted on the
      PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment
      increased the probability to obtain outpatient discharge, even in the presence of
      comorbidities.

      Implications of all available evidence.

      Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials
      have several limitations. It needs results from adequately powered and well-designed clinical
      trials to provide evidence-based guidance on the role of ivermectin in the treatment of
      COVID- 19. However, our study shows overlaps in benefits with other authors, and taking
      together, these results are encouraging for further study about repurposing ivermectin for
      the treatment of COVID-19.
    

Detailed description: 
      Technical Design:

      Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into
      experimental (EG: n = 110) and control groups (CG: n = 144). The criteria for this choice
      were based on the geographical distribution of Health Services, locomotion, and logistics in
      current times of pandemic.

      Sample Size:

      Sample size was determined by the test comparing two proportions. It considered the following
      parameters to the bilateral test: n = 30,000 Total operating area population for services
      network to Primary Care; 95% confidence level, 3% precision, 5% proportion, n = 201 sample
      size without loss, 20% expected proportion of losses. The sample size calculated was n= 252
      participants.

      Participants:

      The total group n = 254 enrolled outpatients care from the urban area-department heads and
      peri-urban area of the City San Miguel de Tucumán. The study was conducted between September
      2020 to January 2021. The health coverage service was administered by the Health System of
      the State of Tucumán (SI.PRO.SA, Tucumán, Argentina). The people who agreed to participate in
      the study gave their informed consent before starting the study (Research Ethics Committee /
      Health Research Directorate, file number 054/2020).

      Intervention Protocol:

      The EG received protocol ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks
      plus symptomatic treatment (500mg paracetamol every 6 or 8h, no more than 4 tablets
      daily;100mg aspirin, 1 tablet per day with breakfast; 150mg Ranitidine, 1 tablet in the
      morning, and 1 tablet at night). The CG received only symptomatic treatment. Patients with
      comorbidities continued with the basic medication for the underlying pathology . All
      participants were evaluated by physical examination and COVID-19 infection was diagnosed with
      positive RT-PCR. Clinical evaluation of symptoms was carried throughout the study period.
      Enrolled subjects completed symptom questionnaires (including reporting of any adverse
      effects of treatment), physical examinations and remote clinical telemedicine follow-up and
      received outpatient discharge 4 weeks after the start of the intervention.

      The 10-category ordinal scale recommended by the WHO was used to classify patients according
      to clinical patient state: ambulatory mild disease, moderate disease, severe disease.
    

Intervention name(s): Ivermectin
Intervention type(s): Drug
Intervention description(s): Experimental Group received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.
Other intervention name(s): N/D
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomised trials.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ivermectin; Outpatient; Mild stage; Health Primary Center