Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan
Condition: Covid19; SARS (Severe Acute Respiratory Syndrome)
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      IMPORTANCE: The emergency of COVID-19 requires the implementation of urgent strategies to
      prevent the spread of the disease, mainly in health personnel, who are the most exposed and
      has the highest risk of becoming infected with the SARS-COV-2.

      OBJECTIVE: To evaluate the protective effect of the combination Ivermectin - Iota-
      Carrageenan, intensive treatment with repeated administration in oral- and nasal-spray,
      respectively, as a prophylaxis treatment prior to exposure to SARS-CoV-2, in health personnel
      at Public Healthcare Centers.

      PARTICIPANTS, DESIGN AND SETTING: Randomized controlled 1-1 clinical trial in Personal
      Health, n = 234. The subjects were divided into experimental (EG)and control groups (CG). The
      EG received Ivermectin orally 2 drops of 6 mg = 12 mg every 7 days, and Iota-Carrageenan 6
      sprays per day for 4 weeks. All participants were evaluated by physical examination COVID-19
      diagnosed with negative RT-PCR at the beginning, final, and follow-up of the protocol.
      Differences between the variables were determined using the Chi-square test. The proportion
      test almost contagious subject and the contagion risk (Odd Ratio) were calculated using
      software STATA. The level of statistical significance was reached when p-Value < 0.05.
    

Detailed description: 
      The subjects were divided into experimental (EG: n=117; 39.6 +/- 9.4 years old, 65F) and
      control groups (CG: n=117; 38.4 +/- 7.4 years old, 61F).

      RESULT: The number of subjects who were diagnosed with COVID-19 in GE was lower, only 4 of
      117 (3.4%) than subjects in CG: 25 of 117 (21.4%) (p-Value = 0.0001). Twenty patients had
      mild symptoms (n= 4 in EG, n= 16 in CG), the proportion test was p-Value = 0.001. Six
      subjects were moderate, and 3 with severe diagnostics, all them in CG. The probability (Odd
      Ratio) of becoming ill with COVID-19 was significantly lower in EG with values of 0.13 (CI =
      [0.03, 0.40]; p-Value = 0.0001), this value (<1) indicates a protective effect of the
      Ivermectin / Iota-Carrageenan in the EG. Logistic regression test demonstrated that
      prophylactic in EG is independent of the patient's preexisting variable comorbidity was 0.11,
      CI= [0.04, 0.33], and p-Value= 0.0001. On the other hand, this variable was 2.78 CI= [1.19,
      6.48], p-Value = 0.018 in CG. Also, we found that when increase the age variable, also
      increases contagious risk for Covid-19 in all subjects 0,93 CI=[0.88, 0.98], p-Value= 0,0012.

      CONCLUSION: The intensive preventive treatment (short-term) with Ivermectin / Iota -
      Carrageenan was able to reduce the number of health workers infected with COVID-19. This
      treatment had an additional effect in preventing the severity of the disease, since most of
      the patients who received the treatment were mild. We propose a new therapeutic alternative
      for prevention and short-term intervention scheme (intensive) that is of benefit of the
      health worker in this pandemic accelerated time. This treatment did not produce lack of
      adherence or adverse effects.

      Trial Registration: CEI (in Spanish: Comité de Ética en Investigación de la Dirección de
      Investigación del SI.PRO.SA, in English: Research Ethics Committee /Health Research
      Directorate) file number 52/2020.
    

Intervention name(s): Ivermectin / Iota-Carrageenan
Intervention type(s): Drug
Intervention description(s): The EG received Ivermectin orally 2 drops of 6 mg = 12 mg every 7 days, and Iota-Carrageenan 6 sprays per day for 4 weeks.
Other intervention name(s): Standard biosecurity care
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled 1:1. Experimental Group and Control Group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ivermectin; Iota-Carrageenan; Prophylaxis Covid-19; Healthcare Agents