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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Covid19 Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)

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Study Type : Observational
Actual Enrollment : 229 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : August 10, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Group/Cohort Intervention/treatment
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.
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)

IVER-
Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only.



Primary Outcome Measures :
  1. Number of Infected Subjects [ Time Frame: 28 days ]
    Number of participants testing positive for COVID-19 after inclusion in each arm


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers testing negative for COVID-19 just before inclusion.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425850


Locations
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Argentina
Hospital Eurnekian
Buenos Aires, Argentina, 1802
Sponsors and Collaborators
Eurnekian Public Hospital
  Study Documents (Full-Text)

Documents provided by Hector E Carvallo, Eurnekian Public Hospital:
Publications:
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Responsible Party: Hector E Carvallo, Principal Investigator, Eurnekian Public Hospital
ClinicalTrials.gov Identifier: NCT04425850    
Other Study ID Numbers: IVERCAR
First Posted: June 11, 2020    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Hector E Carvallo, Eurnekian Public Hospital:
IVERMECTIN CARRAGEENAN COVID 19
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents