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Trial record 1 of 1 for:    NCT04701710
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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

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
Covid19 SARS (Severe Acute Respiratory Syndrome) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
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 : October 15, 2020
Actual Primary Completion Date : December 18, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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 Name: Standard biosecurity care

No Intervention: Control Group
Standard biosecurity care



Primary Outcome Measures :
  1. Pearson's Chi-square and proportion test. [ Time Frame: 4 week ]
    Number of subjects who were diagnosed with COVID-19 in EG and CG.


Secondary Outcome Measures :
  1. Odd Ratio, probabilistic test [ Time Frame: 4 week ]
    Contagion risk. Severity and progression of symptoms.

  2. Logistic regression test [ Time Frame: 4 week ]
    Prophylactic effect associated with patient's preexisting comorbidity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701710


Locations
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Argentina
SI.PRO.SA, Ministerio de Salud Pública
Tucumán, Argentina, 4000
Sponsors and Collaborators
Maria de los Angeles Peral de Bruno
Investigators
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Principal Investigator: Rossana E Chahla, MD, Ph.D. Ministry of Health, Tucuman, Argentina
Publications:
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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: January 8, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/C

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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, Ministry of Public Health, Argentina:
Ivermectin
Iota-Carrageenan
Prophylaxis Covid-19
Healthcare Agents
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents