Covid19Phase 4CARR-COV-02NCT04521322
Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19 Disease
A Phase 4 study testing Iota-Carrageenan in people with Covid19, run by Ariel Dogliotti at 1 site in Argentina.
Trial summary
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteArgentina
- Study dates
- 24 Jul 2020to 30 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
- No more than 48 hours since he/she assisted a COVID-19 patient
- Able to understand and give written informed consent
Who cannot join
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Not having a cell phone with WhatsApp for remote monitoring
- Hypersensitivity or known allergy to any component of the product
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
centro de educación médica e investigaciones clinicas (CEMIC)
Buenos Aires, Buenos Aires F.D., 1425
Mónica Lombardo, MD, 541152990600, mlombardo@nobeltri.com
Ricardo c Valentini, +541152990600, rvalentini@cemic.edu.ar
About this study
Official title: Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19. Multicenter, Randomized, Double-blind, Placebo-controlled Trial (CARR-COV-02)
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.
For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.
Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.
- Conditions
- Covid19
- Being tested
- Iota-Carrageenan
- 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-CarrageenanDrug
Also called Placebo
Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants in this arm will receive a nasal spray with placebo Receives: Drug: Iota-Carrageenan |
| Experimental | Experimental | Participants in this arm will receive a nasal spray with Iota-Carrageenan Receives: Drug: Iota-Carrageenan |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnose of COVID19 disease
COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
Measured: 28 days
Secondary outcomes (3)
Progression to a more severe disease state, defined as need for oxygen therapy.
number of subjects who develop severe COVID19 disease
Measured: 28 days
lasting of disease
number of days with clinical symptoms
Measured: 28 days
Incidence of COVID-19 disease onset in the first week after treatment
number of subjects who develop the disease within one week after finishing treatment
Measured: 1 week after finishing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start24 Jul 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, double blind compared vs placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel Dogliotti
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Responsible party
- Sponsor-investigator, Ariel Dogliotti, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Investigators
- Juan Figueroa, MD, Study director, Instituto Milstein-CONICET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521322
- Sponsor's protocol ID
- CEMIC
- Acronym
- CARR-COV-02
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Figueroa JM, Lombardo ME, Dogliotti A, Flynn LP, Giugliano R, Simonelli G, Valentini R, Ramos A, Romano P, Marcote M, Michelini A, Salvado A, Sykora E, Kniz C, Kobelinsky M, Salzberg DM, Jerusalinsky D, Uchitel O. Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease. Int J Gen Med. 2021 Oct 1;14:6277-6286. doi: 10.2147/IJGM.S328486. eCollection 2021.
PubMed 34629893
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19. Multicenter, Randomized, Double-blind, Placebo-controlled Trial (CARR-COV-02)
- ClinicalTrials.gov ID
- NCT04521322
- Acronym / sponsor ID
- CARR-COV-02 / CEMIC
- Conditions
- Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ariel DogliottiUniversity, hospital or other
- Collaborators
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.
For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.
Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter, randomized, double blind compared vs placebo
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Iota-CarrageenanParticipants in this arm will receive a nasal spray with placebo |
| Experimental | Experimental | Drug: Iota-CarrageenanParticipants in this arm will receive a nasal spray with Iota-Carrageenan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
- No more than 48 hours since he/she assisted a COVID-19 patient
- Able to understand and give written informed consent
Key exclusion criteria (4 listed)
- Participation in any other clinical trial of an experimental treatment for COVID-19
- Not having a cell phone with WhatsApp for remote monitoring
- Hypersensitivity or known allergy to any component of the product
- Pregnancy or lactation
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-CarrageenanAlso: PlaceboParticipants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days | Drug | Control, Experimental |
Primary outcome
diagnose of COVID19 disease
Time frame: 28 days
COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
3 secondary outcomes
Progression to a more severe disease state, defined as need for oxygen therapy.
Time frame: 28 days
lasting of disease
Time frame: 28 days
Incidence of COVID-19 disease onset in the first week after treatment
Time frame: 1 week after finishing treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Derived from this study: PubMed 34629893Figueroa JM, Lombardo ME, Dogliotti A, Flynn LP, Giugliano R, Simonelli G, Valentini R, Ramos A, Romano P, Marcote M, Michelini A, Salvado A, Sykora E, Kniz C, Kobelinsky M, Salzberg DM, Jerusalinsky D, Uchitel O. Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Postexposure Prophylaxis of COVID-19 in Hospital Personnel Dedicated to Patients Care with COVID-19 Disease. Int J Gen Med. 2021 Oct 1;14:6277-6286. doi: 10.2147/IJGM.S328486. eCollection 2021.
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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.
Juan Figueroa, MD study director
Instituto Milstein-CONICET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iota-Carrageenan in people with Covid19, run by Ariel Dogliotti 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mónica Lombardo, MD (005491141763599, mlombardo@nobeltri.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnose of COVID19 disease (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 NCT04521322, which also lists 1 linked publication.
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 21 Aug 2020.