NCT04425850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

June 8, 2020

Results QC Date

August 13, 2020

Last Update Submit

October 15, 2020

Conditions

Covid19

Keywords

IVERMECTIN CARRAGEENAN COVID 19

Outcome Measures

Primary Outcomes (1)

  • Number of Infected Subjects

    Number of participants testing positive for COVID-19 after inclusion in each arm

    28 days

Secondary Outcomes (1)

  • Adverse Events Other Than Those Resulting From Contagion or Disease Progression

    28 days

Study Arms (2)

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)

IVER-

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

Interventions

Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)COMBINATION_PRODUCT

Topical application in the nose and oral cavity

Also known as: Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)
IVER+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers testing negative for COVID-19 just before inclusion.

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity or allergy to any component of the product under evaluation
  • Age under 18 years
  • Use of immunosuppressants (including systemic corticosteroids) in the past 30 days.
  • Pregnant or nursing.
  • Patients with other acute infectious diseases.
  • Patients with autoimmune disease and / or decompensated chronic diseases.
  • Unable to fulfill the administrative tasks proposed by the study.
  • Infection with SARSCoV-2 confirmed by PCR or rapid test authorized by ANMAT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Eurnekian

Buenos Aires, 1802, Argentina

Location

Related Publications (3)

  • Harden EA, Falshaw R, Carnachan SM, Kern ER, Prichard MN. Virucidal activity of polysaccharide extracts from four algal species against herpes simplex virus. Antiviral Res. 2009 Sep;83(3):282-9. doi: 10.1016/j.antiviral.2009.06.007. Epub 2009 Jul 1.

    PMID: 19576248BACKGROUND

  • Carlucci MJ, Scolaro LA, Noseda MD, Cerezo AS, Damonte EB. Protective effect of a natural carrageenan on genital herpes simplex virus infection in mice. Antiviral Res. 2004 Nov;64(2):137-41. doi: 10.1016/j.antiviral.2004.07.001.

    PMID: 15498610BACKGROUND

  • Ashraf S, Prichard R. Ivermectin exhibits potent anti-mitotic activity. Vet Parasitol. 2016 Aug 15;226:1-4. doi: 10.1016/j.vetpar.2016.06.015. Epub 2016 Jun 11.

    PMID: 27514873BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Héctor Carvallo
Organization
Eurnekian Public Hospital
hymcarvallo@hotmail.com
54144800949

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

June 1, 2020

Primary Completion

August 10, 2020

Study Completion

August 10, 2020

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-10

Locations

AR(1)