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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Argentina

SI.PRO.SA, Ministerio de Salud Pública

Tucumán, Argentina, 4000

Sponsors and Collaborators

Maria de los Angeles Peral de Bruno

Investigators

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

More Information

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.

• 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
• 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

• 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:

COVID-19; Severe Acute Respiratory Syndrome; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ivermectin; Antiparasitic Agents; Anti-Infective Agents