Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan

NCT04701710 | Completed Phase 1 DMC

• 1 other identifier: 5076-410-CH2020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome)

Keywords

Ivermectin; Iota-Carrageenan; Prophylaxis Covid-19; Healthcare Agents

Outcome Measures

Primary Outcomes (1)

• Pearson's Chi-square and proportion test.

  Number of subjects who were diagnosed with COVID-19 in EG and CG.

  4 week

Secondary Outcomes (2)

• Odd Ratio, probabilistic test

  4 week

• Logistic regression test

  4 week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Standard biosecurity care

Interventions

Ivermectin / Iota-Carrageenan DRUG

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.

Also known as: Standard biosecurity care

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Personnel who perform patient care and administrative tasks:
• medical personnel,
• nurses,
• kinesiologists,
• orderlies,
• administrative,
• cleaning personnel.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria de los Angeles Peral de Bruno: lead

Study Sites (1)

SI.PRO.SA, Ministerio de Salud Pública

San Miguel de Tucumán, 4000, Argentina

Location

Related Publications (1)

• 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.

  PMID: 32251768 BACKGROUND

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Ivermectin; Carrageenan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Polysaccharides; Carbohydrates

Study Officials

• Rossana E Chahla, MD, Ph.D.

  Ministry of Health, Tucuman, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D in Biological Science

Model Details: Randomized controlled 1:1. Experimental Group and Control Group.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 8, 2021
• Study Start: October 15, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)