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

A Randomized Trial - Intensive Treatment Based in Ivermectin and Iota-carrageenan as Prophylaxis for Covid-19 In Healthcare Agents

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.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Drug: Ivermectin / Iota-Carrageenan

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
• Enrollment (Actual): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Argentina
  • Tucumán, Argentina, 4000
    • SI.PRO.SA, Ministerio de Salud Pública

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Standard biosecurity care
No Intervention: Control Group; Standard biosecurity care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pearson's Chi-square and proportion test.	Number of subjects who were diagnosed with COVID-19 in EG and CG.	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odd Ratio, probabilistic test	Contagion risk. Severity and progression of symptoms.	4 week
Logistic regression test	Prophylactic effect associated with patient's preexisting comorbidity.	4 week

Collaborators and Investigators

• Sponsor: Maria de los Angeles Peral de Bruno
• Investigators: Principal Investigator: Rossana E Chahla, MD, Ph.D., Ministry of Health, Tucuman, Argentina

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Ivermectin; Iota-Carrageenan; Prophylaxis Covid-19; Healthcare Agents
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: 5076-410-CH2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: N/C

Drug and device information, study documents

• 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