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

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

Tracking Information

• First Submitted Date: January 7, 2021
• First Posted Date: January 8, 2021
• Last Update Posted Date: February 23, 2021
• Actual Study Start Date: October 15, 2020
• Actual Primary Completion Date: December 18, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

• Covid19
• SARS (Severe Acute Respiratory Syndrome)

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 7, 2021): 300
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: December 18, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT04701710
• Other Study ID Numbers: 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

• Plan to Share IPD: No
• Plan Description: N/C

• Current Responsible Party: Maria de los Angeles Peral de Bruno, Ministry of Public Health, Argentina
• Original Responsible Party: Same as current
• Current Study Sponsor: Maria de los Angeles Peral de Bruno
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Ministry of Public Health, Argentina
• Verification Date: February 2021