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

USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04425850
Acronym
IVERCAR
Enrollment
229
Registered
2020-06-11
Start date
2020-06-01
Completion date
2020-08-10
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

IVERMECTIN CARRAGEENAN COVID 19

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.

Interventions

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

Topical application in the nose and oral cavity

Sponsors

Eurnekian Public Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Infected Subjects28 daysNumber of participants testing positive for COVID-19 after inclusion in each arm

Secondary

MeasureTime frameDescription
Adverse Events Other Than Those Resulting From Contagion or Disease Progression28 daysAdverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression

Countries

Argentina

Participant flow

Recruitment details

Health personnel

Pre-assignment details

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.

Participants by arm

ArmCount
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. iota carrageenan: topical use on nasal mucosae Ivermectin: Topical use on oral mucosae
131
IVER-
Same as IVER+ They will follow PPEs suggestions, only.
98
Total229

Baseline characteristics

CharacteristicIVER+TotalIVER-
Age, Continuous42 years40 years39 years
Ethnicity (NIH/OMB)
Hispanic or Latino
131 Participants229 Participants98 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
131 Participants229 Participants98 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Argentina
131 Participants229 Participants98 Participants
Sex: Female, Male
Female
70 Participants142 Participants72 Participants
Sex: Female, Male
Male
61 Participants87 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1310 / 98
other
Total, other adverse events
0 / 13111 / 98
serious
Total, serious adverse events
0 / 1310 / 98

Outcome results

Primary

Number of Infected Subjects

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

Time frame: 28 days

Population: Hispanic

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IVER+Number of Infected Subjects0 Participants
IVER-Number of Infected Subjects11 Participants
Comparison: Chi-squared test on the percentage of subjects who contracted COVID-19 in each armp-value: <0.0001Chi-squared
Secondary

Adverse Events Other Than Those Resulting From Contagion or Disease Progression

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

Time frame: 28 days

Population: Hispanic

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
IVER+Adverse Events Other Than Those Resulting From Contagion or Disease Progression0 Participants
IVER-Adverse Events Other Than Those Resulting From Contagion or Disease Progression0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026