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
Z M Jessop, J Gibson, J Y Lim, T H Jovic, E Combellack, T D Dobbs, K Carter, S Hiles, S Islam, B Healy, I Humphreys, R Eccles, H A Hutchings, I S Whitaker
Trials, doi:10.1186/s13063-022-06685-z
Introduction: At present, vaccines form the only mode of prophylaxis against COVID-19. The time needed to achieve mass global vaccination and the emergence of new variants warrants continued research into other COVID-19 prevention strategies. The severity of COVID-19 infection is thought to be associated with the initial viral load, and for infection to occur, viruses including SARS-CoV-2 must first penetrate the respiratory mucus and attach to the host cell surface receptors. Carrageenan, a sulphated polysaccharide extracted from red edible seaweed, has shown efficacy against a wide range of viruses in clinical trials through the prevention of viral entry into respiratory host cells. Carrageenan has also demonstrated in vitro activity against SARS-CoV-2.
Methods and analysis: A single-centre, randomised, double-blinded, placebo-controlled phase III trial was designed. Participants randomised in a 1:1 allocation to either the treatment arm, verum Coldamaris plus (1.2 mg iotacarrageenan (Carragelose ® ), 0.4 mg kappa-carrageenan, 0.5% sodium chloride and purified water), or placebo arm, Coldamaris sine (0.5% sodium chloride) spray applied daily to their nose and throat for 8 weeks, while completing a daily symptom tracker questionnaire for a total of 10 weeks. Primary outcome: Acquisition of COVID-19 infection as confirmed by a positive PCR swab taken at symptom onset or seroconversion during the study. Secondary outcomes include symptom type, severity and duration, subsequent familial/household COVID-19 infection and infection with non-COVID-19 upper respiratory tract infections. A withintrial economic evaluation will be undertaken, with effects expressed as quality-adjusted life years. Discussion: This is a single-centre, phase III, double-blind, randomised placebo-controlled clinical trial to assess whether carrageenan nasal and throat spray reduces the risk of development and severity of COVID-19. If proven effective, the self-administered prophylactic spray would have wider utility for key workers and the general population.
Strengths and limitations of this study • A randomised placebo-controlled double-blind trial • Secondary outcomes designed to improve understanding of the effects of carrageenan nasal and throat sprays on COVID-19 transmission, acquisition, severity and/or duration of resultant infection and other acute respiratory infections • Roll out of the vaccination programme has reduced the eligible participant population from which to recruit
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s13063-022-06685-z.
Additional file 1. Authors' contributions ZMJ conceived the trial idea. ZMJ, JG, KC, SH, HAH, ISW and RE planned the trial. ZMJ, JG, KC, SH, TJ, EC, TDD, BH, IH, RE, HAH and ISW contributed to writing the trial protocol. ZMJ, JG, KC and HAH contributed to seeking ethical approval. ZMJ, JG, SH, TDD and JYL contributed to data collection and monitoring. All the authors read, edited and approved the final manuscript.
Funding This study is funded by Boots Walgreens Alliance and Marinomed Biotech AG. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NHS, Boots Walgreens Alliance or Marinomed Biotech AG. The funders had no role in the study design, data collection, analysis or interpretation.
Declarations Competing interests The authors declare that they have no competing interests.
Publisher's Note Springer Nature remains neutral with regard to..
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