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

Primary Purpose

Covid19, SARS (Severe Acute Respiratory Syndrome)

Status
Completed
Phase
Phase 1
Locations
Argentina
Study Type
Interventional
Intervention
Ivermectin / Iota-Carrageenan
Sponsored by
Maria de los Angeles Peral de Bruno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Ivermectin, Iota-Carrageenan, Prophylaxis Covid-19, Healthcare Agents

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SI.PRO.SA, Ministerio de Salud Pública

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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

Standard biosecurity care

Outcomes

Primary Outcome Measures

Pearson's Chi-square and proportion test.
Number of subjects who were diagnosed with COVID-19 in EG and CG.

Secondary Outcome Measures

Odd Ratio, probabilistic test
Contagion risk. Severity and progression of symptoms.
Logistic regression test
Prophylactic effect associated with patient's preexisting comorbidity.

Full Information

First Posted
January 7, 2021
Last Updated
February 22, 2021
Sponsor
Maria de los Angeles Peral de Bruno
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1. Study Identification

Unique Protocol Identification Number
NCT04701710
Brief Title
Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan
Acronym
Ivercar-Tuc
Official Title
A Randomized Trial - Intensive Treatment Based in Ivermectin and Iota-carrageenan as Prophylaxis for Covid-19 In Healthcare Agents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria de los Angeles Peral de Bruno

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS (Severe Acute Respiratory Syndrome)
Keywords
Ivermectin, Iota-Carrageenan, Prophylaxis Covid-19, Healthcare Agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled 1:1. Experimental Group and Control Group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard biosecurity care
Intervention Type
Drug
Intervention Name(s)
Ivermectin / Iota-Carrageenan
Other Intervention Name(s)
Standard biosecurity care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pearson's Chi-square and proportion test.
Description
Number of subjects who were diagnosed with COVID-19 in EG and CG.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Odd Ratio, probabilistic test
Description
Contagion risk. Severity and progression of symptoms.
Time Frame
4 week
Title
Logistic regression test
Description
Prophylactic effect associated with patient's preexisting comorbidity.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rossana E Chahla, MD, Ph.D.
Organizational Affiliation
Ministry of Health, Tucuman, Argentina
Official's Role
Principal Investigator
Facility Information:
Facility Name
SI.PRO.SA, Ministerio de Salud Pública
City
Tucumán
ZIP/Postal Code
4000
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/C
Citations:
PubMed Identifier
32251768
Citation
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.
Results Reference
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Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan

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