Covid19IVERCARNCT04425850
USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19
An observational study of Covid19, run by Eurnekian Public Hospital at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
- Type of treatment
- Pill or oral medicine
- How many people
- 229 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jun 2020to 10 Aug 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers testing negative for COVID-19 just before inclusion.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
- Keywords
- IVERMECTIN CARRAGEENAN COVID 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)Combination product
Also called Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)
Topical application in the nose and oral cavity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Infected Subjects
Number of participants testing positive for COVID-19 after inclusion in each arm
Measured: 28 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurnekian Public Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hector E Carvallo, Eurnekian Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425850
- Sponsor's protocol ID
- IVERCAR
- Acronym
- IVERCAR
- Status last verified
- Oct 2020
- First submitted
- 8 Jun 2020
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19576248Carlucci 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.
PubMed 15498610Ashraf 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.
PubMed 27514873
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel
- ClinicalTrials.gov ID
- NCT04425850
- Acronym / sponsor ID
- IVERCAR / IVERCAR
- Conditions
- Covid19
- Keywords
- IVERMECTIN CARRAGEENAN COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Eurnekian Public HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVER+ | – | Combination Product: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)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. |
| IVER- | – | –Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers testing negative for COVID-19 just before inclusion.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)Also: Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)Topical application in the nose and oral cavity | Combination product | IVER+ |
Primary outcome
Number of Infected Subjects
Time frame: 28 days
Number of participants testing positive for COVID-19 after inclusion in each arm
1 secondary outcome
Adverse Events Other Than Those Resulting From Contagion or Disease Progression
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19576248Harden 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.
- Background: PubMed 15498610Carlucci 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.
- Background: PubMed 27514873Ashraf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Eurnekian Public Hospital at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Infected Subjects (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425850, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.