COVID-19ICE-COVIDNCT04590365
Carrageenan Nasal Spray for COVID-19 Prophylaxis
A study testing Carrageenan nasal and throat spray and Saline nasal and throat spray in people with COVID-19 and SARS-CoV 2, run by Swansea University at 1 site in United Kingdom.
Trial summary
The current COVID-19 pandemic is the biggest global healthcare challenge in the last century, and the number of cases in the next 12 months is likely to increase. There is currently no proven treatment, chemoprophylaxis or vaccine against COVID-19, which exhibits a wide clinical spectrum from asymptomatic carriage to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- Carrageenan nasal and throat spray and Saline nasal and throat spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2020to 18 Nov 2022
- Phase
- Interventional
- 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
- Age ≥18 years;
- Study participants who have given informed consent, and received a copy of signed consent form prior to any study related procedures;
- Healthcare professionals (nurses, doctors, allied health professionals, health care assistants, operating department practitioners) working in Swansea Bay University Health Board initially as well as any other volunteers >18 years who have not previously tested positive for COVID19 or been vaccinated.
- Subjects agree to refrain from taking over the counter products intended to prevent, intervene in, or treat colds/flu, starting at study entry and continuing through week 10 of the study.
Who cannot join
- Capacity, consent and conflicts of interest:
- The person lacks capacity;
- The subject is related to any study personnel or has any other close ties or conflicts of interest with the research team or the study sponsor;
- The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study.
- Unable to complete the daily symptom tracker
- Unable to communicate in English or Welsh
Show all 18Show fewer
- Comorbidities:
- Known hypersensitivity or allergy to any component of the test product;
- Severe cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease, immune deficiency, autoimmune disease or a history or any current disease that is considered by the investigator as a reason for exclusion;
- Severe nasal septal deviation, nasal polyps or other non-infectious condition that could cause nasal obstruction;
- A history of any nasal or sinus surgery in the past that in the opinion of the investigator may influence the symptoms or spray administration;
- An unrelated infection that in the opinion of the investigator may influence symptoms (gastrointestinal infection, other viral diseases such as measles, mumps);
- COVID-19 Status:
- Participants with proven COVID-19 infection (previous positive serology and/or viral PCR swab)
- Participants that have already received their vaccination or already booked in for their vaccination
- Medications:
- Recent treatment of common cold that in the opinion of the investigator may influence symptoms (see Table 2)
- Participants taking any of the medications outlined in Table 2 during the trial period will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Carrageenan Nasal and Throat Spray for COVID-19 Prophylaxis - A Double Blind Randomised Placebo-controlled Trial
The current COVID-19 pandemic is the biggest global healthcare challenge in the last century, and the number of cases in the next 12 months is likely to increase. There is currently no proven treatment, chemoprophylaxis or vaccine against COVID-19, which exhibits a wide clinical spectrum from asymptomatic carriage to mild upper respiratory tract infection, severe viral pneumonia to acute respiratory distress syndrome and death. Key workers are at high risk of exposure highlighting the need for effective preventative strategies.
SARS-CoV-2 is a positive-sense single-stranded enveloped RNA virus which transmits via droplets, aerosols and direct contact, to reach their target naso- and oropharyngeal epithelial cells through initial electrostatic interactions to cell surface heparan sulphate (HS) proteoglycans. Carrageenan mimics cell surface HS, thereby trapping the virus to allow mucociliary clearance and has demonstrated anti-viral activity in-vitro and in a number of common cold clinical trials when administered as a nasal spray.
ICE-COVID a randomised, double blind, placebo-controlled phase III trial of the prophylactic efficacy of iota-carrageenan nasal and throat spray in preventing COVID-19 illness in at risk healthcare professionals. Participants (n=240) will be randomly allocated to either the treatment arm (verum Coldamaris plus, 0.12% iota-carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine, saline 0.5%) arm. The study's primary objective is the prevention of COVID-19 infection, confirmed by PCR swab or documented seroconversion. Secondary objectives are to determine if carrageenan sprays reduce the clinical severity of COVID-19 and symptomatic acute respiratory infection of other aetiologies (non-SARS-CoV-2).
Read the detailed description
Objectives:
The primary objective is to determine whether carrageenan nasal and throat sprays reduce the risk of COVID-19 infection.
The secondary objectives are:
- To determine whether carrageenan nasal and throat spray reduces the severity and/or duration of COVID-19 infection;
- To determine whether carrageenan nasal and throat spray reduces the risk of infection with other respiratory viruses
- To determine whether carrageenan nasal and throat spray reduces the severity and/or duration of infection with other respiratory viruses
- To determine the usability of carrageenan nasal and throat spray for long term prophylaxis against respiratory viruses
- To determine the effect on of using the spray on quality adjusted life years and cost effectiveness
Study Design:
The study design consists of a double blind, randomised placebo-controlled trial. Of the 480 healthcare professionals recruited, 240 participants will be randomly allocated to each of either the treatment arm (verum Coldamaris plus i.e. Iota-carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine i.e. 0.5% saline) arms. Participants will use the spray prophylactically into each nostril and throat three times per day for 8 weeks, during which time the participants will be invited to complete a daily symptom tracker questionnaire. COVID-19 infection during the trial period will be confirmed using viral PCR swabs (if symptomatic), SARS-CoV-2 serology at 14 days following onset of symptoms as well as trial entry and exit serology to detect asymptomatic infection during the study period.
Allocation to each group, treatment or placebo administration and data analysis will be blinded to both participant and investigator. The primary outcome measure will be acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptoms or positive serology measured 2 weeks after symptom onset or seroconversion at the end of the trial (via trial entry and exit serology) to detect asymptomatic infection during the study period. Secondary outcome measured will include symptom types, severity and duration (recorded by the daily symptom tracker questionnaire), hospital admission and length of stay, oxygen saturation and radiological lung changes on admission, need for ventilatory support (oxygen therapy, CPAP, intubation \& ventilation), haematological changes, intensive care admission and length of stay, mortality, subsequent familial/household COVID-19 infection and acquisition of non-COVID-19 upper respiratory tract infections.
Deliverables:
- This trial will help us to determine whether carrageenan nasal sprays significantly affect the primary outcome measure of acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptoms or positive serology measured 2 weeks after symptom onset or at the end of the study.
- It will also determine the effect of carrageenan nasal sprays on secondary outcome measures which include types, severity and duration of symptoms, hospital admission and length of stay, need for ventilatory support and intensive care admission, mortality as well as familial or household COVID-19 infection and acquisition of other respiratory tract infections.
- We will also investigate whether haematological changes (FBC, CRP, U\&E, Ferritin, LFT, LDH, Clotting, D-dimer, FDP, Vitamin D level) and demographic questionnaire findings can offer a predictive value for acquiring COVID-19 infection or determining severity and/or duration of resultant infection.
- To determine any associations between symptom severity and/or duration and prognosis in those with COVID-19.
- Determine usability and acceptability of nasal and throat spray as prophylaxis and affect on quality adjusted life years and cost effectiveness
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- Carrageenan nasal and throat spray, Saline nasal and throat spray
- Keywords
- Carrageenan, Nasal spray, Anti-viral, Prevention, Carragelose
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrageenan nasal and throat sprayDevice
Iota-carrageenan nasal and throat spray (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline)
Saline nasal and throat sprayDevice
Saline nasal and throat spray (placebo Coldamaris sine i.e. 0.5% saline)
| Study group | Role | What they receive |
|---|---|---|
| Coldamaris plus | Experimental | verum Coldamaris plus i.e. 0.12% Iota-Carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline Receives: Device: Carrageenan nasal and throat spray |
| Coldamaris sine | Placebo comparator | Coldamaris sine i.e. 0.5% saline Receives: Device: Saline nasal and throat spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 infection
Acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptom onset or positive serology measured 2 weeks after symptom onset or seroconversion at the end of the trial (via trial entry and exit serology) to detect asymptomatic infection during the study period
Measured: 9-12 months
Secondary outcomes (4)
Duration of COVID-19 infection
Time taken for all symptoms to resolve (days)
Measured: 9-12 months
Hospitalisation due to COVD-19 infection
Length of hospital and intensive care stay (days)
Measured: 9-12 months
Severity of COVID-19 infection
Morality rate
Measured: 9-12 months
Quality of life of nasal spray use
Usability of spray and effect on cost and quality adjusted life years
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start17 Dec 2020
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design consists of a double blind, randomised placebo-controlled trial. Of the 480 participants recruited, 240 participants will be randomly allocated to each of either the treatment arm (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine i.e. 0.5% saline) arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University, Marinomed Biotech AG, Walgreens Boots Alliance, Abertawe Bro Morgannwg University Health Board
- Responsible party
- Sponsor
- Investigators
- Zita M Jessop, MBBChir PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590365
- Sponsor's protocol ID
- 283187
- Acronym
- ICE-COVID
- Status last verified
- Apr 2022
- First submitted
- 28 May 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buck CB, Thompson CD, Roberts JN, Muller M, Lowy DR, Schiller JT. Carrageenan is a potent inhibitor of papillomavirus infection. PLoS Pathog. 2006 Jul;2(7):e69. doi: 10.1371/journal.ppat.0020069.
PubMed 16839203Eccles R, Meier C, Jawad M, Weinmullner R, Grassauer A, Prieschl-Grassauer E. Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold. Respir Res. 2010 Aug 10;11(1):108. doi: 10.1186/1465-9921-11-108.
PubMed 20696083Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8.
PubMed 26438038Gonzalez ME, Alarcon B, Carrasco L. Polysaccharides as antiviral agents: antiviral activity of carrageenan. Antimicrob Agents Chemother. 1987 Sep;31(9):1388-93. doi: 10.1128/AAC.31.9.1388.
PubMed 2823697Grassauer A, Weinmuellner R, Meier C, Pretsch A, Prieschl-Grassauer E, Unger H. Iota-Carrageenan is a potent inhibitor of rhinovirus infection. Virol J. 2008 Sep 26;5:107. doi: 10.1186/1743-422X-5-107.
PubMed 18817582Ludwig M, Enzenhofer E, Schneider S, Rauch M, Bodenteich A, Neumann K, Prieschl-Grassauer E, Grassauer A, Lion T, Mueller CA. Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial. Respir Res. 2013 Nov 13;14(1):124. doi: 10.1186/1465-9921-14-124.
PubMed 24219370Leibbrandt A, Meier C, Konig-Schuster M, Weinmullner R, Kalthoff D, Pflugfelder B, Graf P, Frank-Gehrke B, Beer M, Fazekas T, Unger H, Prieschl-Grassauer E, Grassauer A. Iota-carrageenan is a potent inhibitor of influenza A virus infection. PLoS One. 2010 Dec 14;5(12):e14320. doi: 10.1371/journal.pone.0014320.
PubMed 21179403Shao Q, Guo Q, Xu Wp, Li Z, Zhao Tt. Specific Inhibitory Effect of kappa-Carrageenan Polysaccharide on Swine Pandemic 2009 H1N1 Influenza Virus. PLoS One. 2015 May 13;10(5):e0126577. doi: 10.1371/journal.pone.0126577. eCollection 2015.
PubMed 25969984Jessop ZM, Gibson J, Lim JY, Jovic TH, Combellack E, Dobbs TD, Carter K, Hiles S, Islam S, Healy B, Humphreys I, Eccles R, Hutchings HA, Whitaker IS. A study protocol for a double-blind randomised placebo-controlled trial evaluating the efficacy of carrageenan nasal and throat spray for COVID-19 prophylaxis-ICE-COVID. Trials. 2022 Sep 15;23(1):782. doi: 10.1186/s13063-022-06685-z.
PubMed 36109791
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Carrageenan Nasal and Throat Spray for COVID-19 Prophylaxis - A Double Blind Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04590365
- Acronym / sponsor ID
- ICE-COVID / 283187
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- Carrageenan, Nasal spray, Anti-viral, Prevention, Carragelose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Cardiff University, Marinomed Biotech AG, Walgreens Boots Alliance, Abertawe Bro Morgannwg University Health Board
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 19 Oct 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.
The current COVID-19 pandemic is the biggest global healthcare challenge in the last century, and the number of cases in the next 12 months is likely to increase. There is currently no proven treatment, chemoprophylaxis or vaccine against COVID-19, which exhibits a wide clinical spectrum from asymptomatic carriage to mild upper respiratory tract infection, severe viral pneumonia to acute respiratory distress syndrome and death. Key workers are at high risk of exposure highlighting the need for effective preventative strategies.
SARS-CoV-2 is a positive-sense single-stranded enveloped RNA virus which transmits via droplets, aerosols and direct contact, to reach their target naso- and oropharyngeal epithelial cells through initial electrostatic interactions to cell surface heparan sulphate (HS) proteoglycans. Carrageenan mimics cell surface HS, thereby trapping the virus to allow mucociliary clearance and has demonstrated anti-viral activity in-vitro and in a number of common cold clinical trials when administered as a nasal spray.
ICE-COVID a randomised, double blind, placebo-controlled phase III trial of the prophylactic efficacy of iota-carrageenan nasal and throat spray in preventing COVID-19 illness in at risk healthcare professionals. Participants (n=240) will be randomly allocated to either the treatment arm (verum Coldamaris plus, 0.12% iota-carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine, saline 0.5%) arm. The study's primary objective is the prevention of COVID-19 infection, confirmed by PCR swab or documented seroconversion. Secondary objectives are to determine if carrageenan sprays reduce the clinical severity of COVID-19 and symptomatic acute respiratory infection of other aetiologies (non-SARS-CoV-2).
Detailed description
Objectives:
The primary objective is to determine whether carrageenan nasal and throat sprays reduce the risk of COVID-19 infection.
The secondary objectives are:
- To determine whether carrageenan nasal and throat spray reduces the severity and/or duration of COVID-19 infection;
- To determine whether carrageenan nasal and throat spray reduces the risk of infection with other respiratory viruses
- To determine whether carrageenan nasal and throat spray reduces the severity and/or duration of infection with other respiratory viruses
- To determine the usability of carrageenan nasal and throat spray for long term prophylaxis against respiratory viruses
- To determine the effect on of using the spray on quality adjusted life years and cost effectiveness
Study Design:
The study design consists of a double blind, randomised placebo-controlled trial. Of the 480 healthcare professionals recruited, 240 participants will be randomly allocated to each of either the treatment arm (verum Coldamaris plus i.e. Iota-carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine i.e. 0.5% saline) arms. Participants will use the spray prophylactically into each nostril and throat three times per day for 8 weeks, during which time the participants will be invited to complete a daily symptom tracker questionnaire. COVID-19 infection during the trial period will be confirmed using viral PCR swabs (if symptomatic), SARS-CoV-2 serology at 14 days following onset of symptoms as well as trial entry and exit serology to detect asymptomatic infection during the study period.
Allocation to each group, treatment or placebo administration and data analysis will be blinded to both participant and investigator. The primary outcome measure will be acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptoms or positive serology measured 2 weeks after symptom onset or seroconversion at the end of the trial (via trial entry and exit serology) to detect asymptomatic infection during the study period. Secondary outcome measured will include symptom types, severity and duration (recorded by the daily symptom tracker questionnaire), hospital admission and length of stay, oxygen saturation and radiological lung changes on admission, need for ventilatory support (oxygen therapy, CPAP, intubation \& ventilation), haematological changes, intensive care admission and length of stay, mortality, subsequent familial/household COVID-19 infection and acquisition of non-COVID-19 upper respiratory tract infections.
Deliverables:
- This trial will help us to determine whether carrageenan nasal sprays significantly affect the primary outcome measure of acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptoms or positive serology measured 2 weeks after symptom onset or at the end of the study.
- It will also determine the effect of carrageenan nasal sprays on secondary outcome measures which include types, severity and duration of symptoms, hospital admission and length of stay, need for ventilatory support and intensive care admission, mortality as well as familial or household COVID-19 infection and acquisition of other respiratory tract infections.
- We will also investigate whether haematological changes (FBC, CRP, U\&E, Ferritin, LFT, LDH, Clotting, D-dimer, FDP, Vitamin D level) and demographic questionnaire findings can offer a predictive value for acquiring COVID-19 infection or determining severity and/or duration of resultant infection.
- To determine any associations between symptom severity and/or duration and prognosis in those with COVID-19.
- Determine usability and acceptability of nasal and throat spray as prophylaxis and affect on quality adjusted life years and cost effectiveness
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design consists of a double blind, randomised placebo-controlled trial. Of the 480 participants recruited, 240 participants will be randomly allocated to each of either the treatment arm (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline) or placebo (Coldamaris sine i.e. 0.5% saline) arms.
| Arm | Type | Receives |
|---|---|---|
| Coldamaris plus | Experimental | Device: Carrageenan nasal and throat sprayverum Coldamaris plus i.e. 0.12% Iota-Carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline |
| Coldamaris sine | Placebo comparator | Device: Saline nasal and throat sprayColdamaris sine i.e. 0.5% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Study participants who have given informed consent, and received a copy of signed consent form prior to any study related procedures;
- Healthcare professionals (nurses, doctors, allied health professionals, health care assistants, operating department practitioners) working in Swansea Bay University Health Board initially as well as any other volunteers >18 years who have not previously tested positive for COVID19 or been vaccinated.
- Subjects agree to refrain from taking over the counter products intended to prevent, intervene in, or treat colds/flu, starting at study entry and continuing through week 10 of the study.
Key exclusion criteria (18 listed)
- The person lacks capacity;
- The subject is related to any study personnel or has any other close ties or conflicts of interest with the research team or the study sponsor;
- The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study.
- Unable to complete the daily symptom tracker
- Unable to communicate in English or Welsh
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 |
|---|---|---|
| Carrageenan nasal and throat sprayIota-carrageenan nasal and throat spray (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline) | Device | Coldamaris plus |
| Saline nasal and throat spraySaline nasal and throat spray (placebo Coldamaris sine i.e. 0.5% saline) | Device | Coldamaris sine |
Primary outcome
Rate of COVID-19 infection
Time frame: 9-12 months
Acquisition of COVID-19 infection as confirmed by positive PCR swab taken at the time of symptom onset or positive serology measured 2 weeks after symptom onset or seroconversion at the end of the trial (via trial entry and exit serology) to detect asymptomatic infection during the study period
4 secondary outcomes
Duration of COVID-19 infection
Time frame: 9-12 months
Hospitalisation due to COVD-19 infection
Time frame: 9-12 months
Severity of COVID-19 infection
Time frame: 9-12 months
Quality of life of nasal spray use
Time frame: 9-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 16839203Buck CB, Thompson CD, Roberts JN, Muller M, Lowy DR, Schiller JT. Carrageenan is a potent inhibitor of papillomavirus infection. PLoS Pathog. 2006 Jul;2(7):e69. doi: 10.1371/journal.ppat.0020069.
- Background: PubMed 20696083Eccles R, Meier C, Jawad M, Weinmullner R, Grassauer A, Prieschl-Grassauer E. Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold. Respir Res. 2010 Aug 10;11(1):108. doi: 10.1186/1465-9921-11-108.
- Background: PubMed 26438038Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8.
- Background: PubMed 2823697Gonzalez ME, Alarcon B, Carrasco L. Polysaccharides as antiviral agents: antiviral activity of carrageenan. Antimicrob Agents Chemother. 1987 Sep;31(9):1388-93. doi: 10.1128/AAC.31.9.1388.
- Background: PubMed 18817582Grassauer A, Weinmuellner R, Meier C, Pretsch A, Prieschl-Grassauer E, Unger H. Iota-Carrageenan is a potent inhibitor of rhinovirus infection. Virol J. 2008 Sep 26;5:107. doi: 10.1186/1743-422X-5-107.
- Background: PubMed 24219370Ludwig M, Enzenhofer E, Schneider S, Rauch M, Bodenteich A, Neumann K, Prieschl-Grassauer E, Grassauer A, Lion T, Mueller CA. Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial. Respir Res. 2013 Nov 13;14(1):124. doi: 10.1186/1465-9921-14-124.
- Background: PubMed 21179403Leibbrandt A, Meier C, Konig-Schuster M, Weinmullner R, Kalthoff D, Pflugfelder B, Graf P, Frank-Gehrke B, Beer M, Fazekas T, Unger H, Prieschl-Grassauer E, Grassauer A. Iota-carrageenan is a potent inhibitor of influenza A virus infection. PLoS One. 2010 Dec 14;5(12):e14320. doi: 10.1371/journal.pone.0014320.
- Background: PubMed 25969984Shao Q, Guo Q, Xu Wp, Li Z, Zhao Tt. Specific Inhibitory Effect of kappa-Carrageenan Polysaccharide on Swine Pandemic 2009 H1N1 Influenza Virus. PLoS One. 2015 May 13;10(5):e0126577. doi: 10.1371/journal.pone.0126577. eCollection 2015.
- Derived from this study: PubMed 36109791Jessop ZM, Gibson J, Lim JY, Jovic TH, Combellack E, Dobbs TD, Carter K, Hiles S, Islam S, Healy B, Humphreys I, Eccles R, Hutchings HA, Whitaker IS. A study protocol for a double-blind randomised placebo-controlled trial evaluating the efficacy of carrageenan nasal and throat spray for COVID-19 prophylaxis-ICE-COVID. Trials. 2022 Sep 15;23(1):782. doi: 10.1186/s13063-022-06685-z.
- Individual participant dataSharing planned: No
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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.
Zita M Jessop, MBBChir PhD principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrageenan nasal and throat spray and Saline nasal and throat spray in people with COVID-19 and SARS-CoV 2, run by Swansea University at 1 site in United Kingdom.
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 18 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 28 Apr 2023. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of COVID-19 infection (time frame: 9-12 months). 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 NCT04590365, which also lists 9 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 28 Apr 2023.