COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04590365

Jessop Z

None

2020-10-19

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

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

2

Swansea University

18

100

United Kingdom

Health workers

N/A

480

Rate of COVID-19 infection

None

Not reported

[{"arm_notes": "Iota-carrageenan nasal and throat spray", "treatment_id": 254, "treatment_name": "Carrageenan", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]