Ivercar-Tuc: Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan

Sponsor
Maria de los Angeles Peral de Bruno (Other)
Overall Status
Completed
CT.gov ID
NCT04701710
Collaborator
(none)
300
1
2
2.5
118.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ivermectin / Iota-Carrageenan
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled 1:1. Experimental Group and Control Group.Randomized controlled 1:1. Experimental Group and Control Group.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized Trial - Intensive Treatment Based in Ivermectin and Iota-carrageenan as Prophylaxis for Covid-19 In Healthcare Agents
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

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. Standard biosecurity care

Drug: Ivermectin / Iota-Carrageenan
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 Names:
  • Standard biosecurity care
  • No Intervention: Control Group

    Standard biosecurity care

    Outcome Measures

    Primary Outcome Measures

    1. Pearson's Chi-square and proportion test. [4 week]

      Number of subjects who were diagnosed with COVID-19 in EG and CG.

    Secondary Outcome Measures

    1. Odd Ratio, probabilistic test [4 week]

      Contagion risk. Severity and progression of symptoms.

    2. Logistic regression test [4 week]

      Prophylactic effect associated with patient's preexisting comorbidity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Personnel who perform patient care and administrative tasks:

    • medical personnel,

    • nurses,

    • kinesiologists,

    • orderlies,

    • administrative,

    • cleaning personnel.

    Exclusion Criteria:
    • People under 18 years of age,

    • Pregnant or actively breastfeeding women,

    • Presenting symptoms related to COVID-19 disease,

    • Concurrent autoimmune or chronic disease,

    • Immunosuppression,

    • Active infectious diseases,

    • History of previous SARSCoV-2 infection confirmed by RT-PCR or rapid test.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SI.PRO.SA, Ministerio de Salud Pública Tucumán Argentina 4000

    Sponsors and Collaborators

    • Maria de los Angeles Peral de Bruno

    Investigators

    • Principal Investigator: Rossana E Chahla, MD, Ph.D., Ministry of Health, Tucuman, Argentina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maria de los Angeles Peral de Bruno, Ph.D in Biological Science, Ministry of Public Health, Argentina
    ClinicalTrials.gov Identifier:
    NCT04701710
    Other Study ID Numbers:
    • 5076-410-CH2020
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Maria de los Angeles Peral de Bruno, Ph.D in Biological Science, Ministry of Public Health, Argentina
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2021