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Trial record 1 of 1 for:    NCT04425850
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USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19 (IVERCAR)

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ClinicalTrials.gov Identifier: NCT04425850
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hector E Carvallo, Eurnekian Public Hospital

Tracking Information
First Submitted Date June 8, 2020
First Posted Date June 11, 2020
Results First Submitted Date August 13, 2020
Results First Posted Date October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date June 1, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2020)
Number of Infected Subjects [ Time Frame: 28 days ]
Number of participants testing positive for COVID-19 after inclusion in each arm
Original Primary Outcome Measures
 (submitted: June 8, 2020)
Reduction in contagion [ Time Frame: 30 days ]
For Health Personnel, this is a crucial point, since the average dessertion all over the world has raised to 27 % of personnel involved in first line assistance
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2020)
Adverse Events Other Than Those Resulting From Contagion or Disease Progression [ Time Frame: 28 days ]
Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression
Original Secondary Outcome Measures
 (submitted: June 8, 2020)
Secondary and or side effects [ Time Frame: 7 days ]
Allergy to any of the two drugs administered topically
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19
Official Title USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel
Brief Summary

Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections is critical for understanding the overall prevalence and pandemic potential of this disease.

It is estimated that 86% of all infections were undocumented [95% credible interval (CI): 82-90%] before the 23 January 2020 travel restrictions. The transmission rate of undocumented infections per person was 55% the transmission rate of documented infections (95% CI: 46-62%), yet, because of their greater numbers, undocumented infections were the source of 79% of the documented cases.

Ivermectin + Carrageenan, taking advantage of their virucidal effects, are aimed at reducing the contagion.

Detailed Description

CONTAGION COURSE Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections is critical for understanding the overall prevalence and pandemic potential of this disease.

Observations of reported infection within China, in conjunction with mobility data, a networked dynamic metapopulation model, and Bayesian inference, to infer critical epidemiological characteristics associated with SARS-CoV-2, including the fraction of undocumented infections and their contagiousness, have been attempted. The rapid geographic spread of SARS-CoV-2 indicate that containment of this virus will be particularly challenging.

DISSEMINATION BY DROPLETS For COVID-19, the salivary gland could be an important source of the virus in saliva and would generate infectious saliva on a sustained basis.

ACE2 expression in the minor salivary glands was higher than in the lungs, suggesting that the salivary glands is a potential target for COVID-19.

The positive rate of COVID-19 in the patients' saliva can reach 91.7%, and the saliva samples can also culture the live virus.

In addition to mobility restrictions of people, the World Health Organization and the Governments have prescribed maintaining an inter-personal distance of 1.5 or 2 m (about 6 feet) from each other in order to minimize the risk of contagion through the droplets that we usually disseminate around us from nose and mouth. However, recently published studies support the hypothesis of virus transmission over a distance of 2 m from an infected person. Researchers have proved the higher aerosol and surface stability of SARS-COV-2 as compared with SARS-COV-1 (with the virus remaining viable and infectious in aerosol for hours) and that airborne transmission of SARS-CoV can occur besides close-distance contacts. Indeed, there is reasonable evidence about the possibility of SARS-COV-2 airborne transmission due to its persistence into aerosol droplets in a viable and infectious form. Based on the available knowledge and epidemiological observations, it is plausible that small particles containing the virus may diffuse in indoor environments covering distances up to 10 m from the emission sources, thus representing a kind of aerosol transmission. On-field studies carried out inside Wuhan Hospitals showed the presence of SARS-COV-2 RNA in air samples collected in the hospitals and also in the surroundings, leading to the conclusion that the airborne route has to be considered an important pathway for viral diffusion. Similar findings are reported in analyses concerning air samples collected at the Nebraska University Hospital. On March 16th, we have released a Position Paper emphasizing the airborne route as a possible additional factor for interpreting the anomalous COVID-19 outbreaks in northern Italy, ranked as one of the most polluted areas in Europe and characterized by high particulate matter (PM) concentrations. The available information on the SARS-COV-2 spreading supports the hypothesis of airborne diffusion of infected droplets from person to person at a distance greater than two meters (6 feet). The inter-personal distance of 2 m can be reasonably considered as an effective protection only if everybody wears face masks in daily life activities.

IVERMECTIN CONCENTRATION IN SALIVARY GLANDS The concentration of ivermectin was tested in different tissues, in different studies, both in animals and human beings. The concentration in salivary glands proved to be adequately acceptable.

CARRAGEENAN VIRUCIDAL EFFECTS Iota Carrageenan is widely used in gastronomic, cosmetic and pharmacologic industry.

Recently, its intrinsic virucidal effectas were proved over a variety of virus (herpes simplex, Japanese Encephalitis, Rhinovirus, etc.).

Its mechanism of action is preventing virus adsorption to host cells. By applying both drugs topically, 5 times per day, in nasal and oral mucosae, we try to reduce contagion.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy volunteers testing negative for COVID-19 just before inclusion.
Condition Covid19
Intervention Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
Topical application in the nose and oral cavity
Other Name: Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)
Study Groups/Cohorts
  • IVER+
    Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. They will follow standard prophylactic measures and use PPE as suggested by OMS.
    Intervention: Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
  • IVER-
    Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2020)
229
Original Estimated Enrollment
 (submitted: June 8, 2020)
70
Actual Study Completion Date August 10, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  1. Not younger than 18 years of either sex
  2. Health personnel from the Dr. Alberto Eurnekian Interzonal University Hospital
  3. No COVID-19 related symptoms
  4. Able to understand and give written informed consent

Exclusion criteria

  1. Known hypersensitivity or allergy to any component of the product under evaluation
  2. Age under 18 years
  3. Use of immunosuppressants (including systemic corticosteroids) in the past 30 days.
  4. Pregnant or nursing.
  5. Patients with other acute infectious diseases.
  6. Patients with autoimmune disease and / or decompensated chronic diseases.
  7. Unable to fulfill the administrative tasks proposed by the study.
  8. Infection with SARSCoV-2 confirmed by PCR or rapid test authorized by ANMAT.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT04425850
Other Study ID Numbers IVERCAR
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: Undecided
Responsible Party Hector E Carvallo, Eurnekian Public Hospital
Study Sponsor Eurnekian Public Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Eurnekian Public Hospital
Verification Date October 2020