Carrageenan Nasal Spray for COVID-19 Prophylaxis

Summary

Participation Requirements

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 ...

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

Tracking Information