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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 : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : June 17, 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
Contagious Pleuropneumonia Device: iota carrageenan Drug: Ivermectin

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Study Type : Observational
Estimated Enrollment : 70 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
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 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. PPEs used as suggested by OMS.
Device: iota carrageenan
topical use on nasal mucosae
Other Name: Nasitral

Drug: Ivermectin
Topical use on oral mucosae
Other Name: Ivercass

IVER-
Same as IVER+ They will follow PPEs suggestions, only.



Primary Outcome Measures :
  1. Reduction in contagion [ Time Frame: 30 days ]
    For Health Personnel, the average dessertion all over the world has raised to 27 % worldwide. We aim at reducing it dramaticaly.


Secondary Outcome Measures :
  1. Secondary and or side effects [ Time Frame: 7 days ]
    Allergy to any of the two drugs administered topically



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
It includes volunteers for both cohorts, provided they have teste negative for COVID 19 in swabs obtained immediately befor inclusion.
Criteria

Inclusion Criteria:

Negative oral/nasal swabs

Exclusion Criteria:

Ages 4 or under Pregnant women Previous record of allergy to the above mentioned drugs


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
Publications of Results:
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Responsible Party: Hector E Carvallo, Estudio de eficacia y seguridad de Ivermectina y iota-Carragenina local, en la profilaxis del personal de salud y convivientes de pacientes COVID-19 positivos. Ensayo multicéntrico, prospectivo, aleatorizado, comparativo contra el cuidado estándar., Eurnekian Public Hospital
ClinicalTrials.gov Identifier: NCT04425850    
Other Study ID Numbers: IVERCAR
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
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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Pleuropneumonia, Contagious
Pleuropneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasma Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Ivermectin
Antiparasitic Agents
Anti-Infective Agents