ClinicalTrials.gov

History of Changes for Study: NCT04701710
PROPHYLAXIS COVID-19 IN HEALTHCARE AGENTS BY INTENSIVE TREATMENT WITH IVERMECTIN AND IOTA-CARRAGEENAN (IVERCAR-TUC)
Latest version (submitted February 22, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 January 7, 2021 None (earliest Version on record)
2 January 8, 2021 Outcome Measures, Arms and Interventions, Study Identification, Conditions, Eligibility, Study Description and Study Status
3 February 22, 2021 Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Study NCT04701710
Submitted Date:  January 7, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5076-410-CH2020
Brief Title: PROPHYLAXIS COVID-19 IN HEALTHCARE AGENTS BY INTENSIVE TREATMENT WITH IVERMECTIN AND IOTA-CARRAGEENAN (IVERCAR-TUC)
Official Title: A RANDOMIZED TRIAL - INTENSIVE TREATMENT BASED IN IVERMECTIN AND IOTACARRAGEENAN AS PROPHYLAXIS FOR COVID-19 IN HEALTHCARE AGENTS
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2021
Overall Status: Completed
Study Start: October 15, 2020
Primary Completion: December 18, 2020 [Actual]
Study Completion: December 31, 2020 [Actual]
First Submitted: January 7, 2021
First Submitted that
Met QC Criteria:
January 7, 2021
First Posted: January 8, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
January 7, 2021
Last Update Posted: January 8, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Maria de los Angeles Peral de Bruno
Responsible Party: Sponsor-Investigator
Investigator: Maria de los Angeles Peral de Bruno
Official Title: Ph.D in Biological Science
Affiliation: Ministry of Public Health, Argentina
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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:
Open or close this module Conditions
Conditions: Pharmacological Action
Keywords: IVERMECTIN
IOTA-CARRAGEENAN
PROPHYLAXIS COVID- 19
HEALTHCARE AGENTS
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Randomized controlled 1:1. Experimental Group and Control Group.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Drug: Ivermectin
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:
  • IOTA-CARRAGEENAN
No Intervention: Control Group
Standard biosecurity care and personal protective equipment (PPE)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Reduce the number of COVID-19 infections in health personnel
[ Time Frame: 4 week ]

Intensive prophylactic treatment of Ivermectin associated with Iota-Carrageenan.
Secondary Outcome Measures:
1. Reduce the severity and progression of symptoms
[ Time Frame: 4 week ]

Intensive prophylactic treatment of Ivermectin associated with Iota-Carrageenan.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Personnel who perform patient care and administrative tasks, that is: medical personnel, nurses, kinesiologists, orderlies, administrative and 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, and a history of previous SARSCoV-2 infection. confirmed by RT-PCR or rapid test
Open or close this module Contacts/Locations
Study Officials: Rossana E Chala, MD, Ph.D.
Principal Investigator
Ministry of Health, Tucuman, Argentina
Locations: Argentina
SI.PRO.SA, Ministerio de Salud Pública
Tucumán, Argentina, 4000
Open or close this module IPDSharing
Plan to Share IPD: No
N/C
Open or close this module References
Citations: 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. PubMed 32251768
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services