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

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ClinicalTrials.gov Identifier: NCT04701710
Recruitment Status : Completed
First Posted : January 8, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Maria de los Angeles Peral de Bruno, Ministry of Public Health, Argentina

Tracking Information
First Submitted Date  ICMJE January 7, 2021
First Posted Date  ICMJE January 8, 2021
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE October 15, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
Pearson's Chi-square and proportion test. [ Time Frame: 4 week ]
Number of subjects who were diagnosed with COVID-19 in EG and CG.
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
Reduce the number of COVID-19 infections in health personnel [ Time Frame: 4 week ]
Intensive prophylactic treatment of Ivermectin associated with Iota-Carrageenan.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
  • Odd Ratio, probabilistic test [ Time Frame: 4 week ]
    Contagion risk. Severity and progression of symptoms.
  • Logistic regression test [ Time Frame: 4 week ]
    Prophylactic effect associated with patient's preexisting comorbidity.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
Reduce the severity and progression of symptoms [ Time Frame: 4 week ]
Intensive prophylactic treatment of Ivermectin associated with Iota-Carrageenan.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan
Official Title  ICMJE A Randomized Trial - Intensive Treatment Based in Ivermectin and Iota-carrageenan as Prophylaxis for Covid-19 In Healthcare Agents
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE 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 Name: Standard biosecurity care
Study Arms  ICMJE
  • 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

    Intervention: Drug: Ivermectin / Iota-Carrageenan
  • No Intervention: Control Group
    Standard biosecurity care
Publications * Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2021)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04701710
Other Study ID Numbers  ICMJE 5076-410-CH2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: N/C
Responsible Party Maria de los Angeles Peral de Bruno, Ministry of Public Health, Argentina
Study Sponsor  ICMJE Maria de los Angeles Peral de Bruno
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rossana E Chahla, MD, Ph.D. Ministry of Health, Tucuman, Argentina
PRS Account Ministry of Public Health, Argentina
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP