IVERCAR: USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19

• Sponsor: Eurnekian Public Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04425850
• Collaborator: (none)
• Enrollment: 229
• Location: 1
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 99.6

Study Details

Study Description

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	Phase
Covid19	Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)

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 Design

• 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: Jun 1, 2020
• Actual Primary Completion Date: Aug 10, 2020
• Actual Study Completion Date: Aug 10, 2020

Arms and Interventions

Arm	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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Infected Subjects [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 [28 days]

   Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Eurnekian	Buenos Aires		Argentina	1802

Sponsors and Collaborators

• Eurnekian Public Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 29, 2020

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Hector E Carvallo, Principal Investigator, Eurnekian Public Hospital
• ClinicalTrials.gov Identifier: NCT04425850
• Other Study ID Numbers: IVERCAR
• First Posted: Jun 11, 2020
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Principal Investigator, Eurnekian Public Hospital: IVERMECTIN CARRAGEENAN COVID 19
• Additional relevant MeSH terms: COVID-19; Ivermectin

Study Results

Participant Flow

Recruitment Details	Health personnel
Pre-assignment Detail	Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out. It includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion.

Arm/Group Title	IVER+	IVER-
Arm/Group Description	Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal)	Standard prophylactic measures and PPE only
Period Title: Overall Study
STARTED	131	98
COMPLETED	131	98
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	IVER+	IVER-	Total
Arm/Group Description	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. iota carrageenan: topical use on nasal mucosae Ivermectin: Topical use on oral mucosae	Same as IVER+ They will follow PPEs suggestions, only.	Total of all reporting groups
Overall Participants	131	98	229
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	42	39	40
Sex: Female, Male (Count of Participants)
Female	70 53.4%	72 73.5%	142 62%
Male	61 46.6%	26 26.5%	87 38%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	131 100%	98 100%	229 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	131 100%	98 100%	229 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Argentina	131 100%	98 100%	229 100%

Outcome Measures

1. Primary Outcome

Title	Number of Infected Subjects
Description	Number of participants testing positive for COVID-19 after inclusion in each arm
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Hispanic

Arm/Group Title	IVER+	IVER-
Arm/Group Description	Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)	Standard prophylactic measures and PPEs only
Measure Participants	131	98
Count of Participants [Participants]	0 0%	11 11.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IVER+, IVER-
	Comments	Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Adverse Events Other Than Those Resulting From Contagion or Disease Progression
Description	Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Hispanic

Arm/Group Title	IVER+	IVER-
Arm/Group Description	Standard prophylactic measures and PPE + Treatment with iota carragenan (nasal and buccal) and ivermectin (buccal only)	Standard prophylactic measures and PPE only
Measure Participants	131	98
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Medical examination Chart of adverse events filled in by subjects
Arm/Group Title	IVER+		IVER-
Arm/Group Description	Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal).		Standard prophylactic measures and PPEs only
All Cause Mortality
	IVER+		IVER-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/98 (0%)
Serious Adverse Events
	IVER+		IVER-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	IVER+		IVER-
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		11/98 (11.2%)
Infections and infestations
Contagion	0/131 (0%)	0	11/98 (11.2%)	11

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.