![]() In December 2019, clusters of patients presenting with severe pneumonia of unknown origin were reported in the city of Wuhan, Hubei Provence, China. If proven effective, the self-administered prophylactic spray would have wider utility for key workers and the general population. 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. A within-trial economic evaluation will be undertaken, with effects expressed as quality-adjusted life years. ![]() Secondary outcomes include symptom type, severity and duration, subsequent familial/household COVID-19 infection and infection with non-COVID-19 upper respiratory tract infections. Primary outcomeĪcquisition of COVID-19 infection as confirmed by a positive PCR swab taken at symptom onset or seroconversion during the study. Participants randomised in a 1:1 allocation to either the treatment arm, verum Coldamaris plus (1.2 mg iota-carrageenan (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. Methods and analysisĪ single-centre, randomised, double-blinded, placebo-controlled phase III trial was designed. Carrageenan has also demonstrated in vitro activity against SARS-CoV-2. 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. 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. ![]() The time needed to achieve mass global vaccination and the emergence of new variants warrants continued research into other COVID-19 prevention strategies. At present, vaccines form the only mode of prophylaxis against COVID-19. ![]()
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