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Trial record 1 of 1 for:    NCT04590365
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Carrageenan Nasal Spray for COVID-19 Prophylaxis (ICE-COVID)

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ClinicalTrials.gov Identifier: NCT04590365
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
Cardiff University
Marinomed Biotech AG
Walgreens Boots Alliance
Abertawe Bro Morgannwg University Health Board
Information provided by (Responsible Party):
Swansea University

Brief 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 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).


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Device: Carrageenan nasal and throat spray Device: Saline nasal and throat spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Allocation to each group, treatment or placebo administration and data analysis will be blinded to both participant and investigator. The sprays will be blinded at the site of manufacture. Trial sealed envelopes will be available in case of any adverse reactions.
Primary Purpose: Prevention
Official Title: Efficacy of Carrageenan Nasal and Throat Spray for COVID-19 Prophylaxis - A Double Blind Randomised Placebo-controlled Trial
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: Coldamaris plus
verum Coldamaris plus i.e. 0.12% Iota-Carrageenan plus 0.04% Kappa-Carrageenan in 0.5% saline
Device: Carrageenan nasal and throat spray
Iota-carrageenan nasal and throat spray (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline)

Placebo Comparator: Coldamaris sine
Coldamaris sine i.e. 0.5% saline
Device: Saline nasal and throat spray
Saline nasal and throat spray (placebo Coldamaris sine i.e. 0.5% saline)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of COVID-19 infection [ Time Frame: 9-12 months ]
    Time taken for all symptoms to resolve (days)

  2. Hospitalisation due to COVD-19 infection [ Time Frame: 9-12 months ]
    Length of hospital and intensive care stay (days)

  3. Severity of COVID-19 infection [ Time Frame: 9-12 months ]
    Morality rate

  4. Quality of life of nasal spray use [ Time Frame: 9-12 months ]
    Usability of spray and effect on cost and quality adjusted life years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590365


Contacts
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Contact: Zita M Jessop, MBBChir PhD 07743684868 z.m.jessop@swansea.ac.uk
Contact: Iain S Whitaker, PhD FRCS 07525249048 iainwhitaker@fastmail.fm

Locations
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United Kingdom
Joint Clinical Research Facility Recruiting
Swansea, United Kingdom, SA6 6NL
Contact: Claire Stafford    07742674767    Claire.Stafford@wales.nhs.uk   
Contact: Lucy Barlow    07742674767    Lucy.Barlow@wales.nhs.uk   
Sponsors and Collaborators
Swansea University
Cardiff University
Marinomed Biotech AG
Walgreens Boots Alliance
Abertawe Bro Morgannwg University Health Board
Investigators
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Principal Investigator: Zita M Jessop, MBBChir PhD Swansea University
Publications:

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Responsible Party: Swansea University
ClinicalTrials.gov Identifier: NCT04590365    
Other Study ID Numbers: 283187
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swansea University:
Carrageenan
Nasal spray
Anti-viral
Prevention
Carragelose
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases