NOCOVID (NCT04337918).

Study name	'Multi‐center, randomized, controlled, phase II clinical efficacy study evaluating nitric oxide releasing solution treatment for the prevention and treatment of COVID‐19 in healthcare workers and individuals at risk of infection'
Methods	Multicentre, parallel‐group, single‐blind randomised controlled trial
Participants	Healthcare workers and individuals who are negative for COVID‐19 during screening, aged 19 years and over Inclusion criteria: Capacity to consent to participation 19 years of age or older English speaking Willing to use adequate contraception for the duration of the trial Symptom free at screening/baseline Working/living in contact with COVID‐19 infected patients, or scheduled to work in a setting with high likelihood of exposure to COVID‐19 infected patients Exclusion criteria: Prior tracheostomy Concomitant treatment of respiratory support (involving any form of oxygen therapy) Any clinical contraindications, as judged by the attending physician Any symptoms consistent with COVID‐19 Pregnancy Mentally or neurologically disabled participants who are not considered fit to consent to the study Prior COVID‐19 infection Planned sample size: 200 participants
Interventions	Intervention group: Daily self‐administration of nitric oxide gargle every morning, nitric oxide nasopharyngeal irrigation every evening and nitric oxide nasal spray up to 5 times per day, for 14 days Comparator group: No intervention Use of additional interventions in both groups: All participants will receive standard institutional precautions
Outcomes	Primary outcome: Proportion of healthcare workers with either positive COVID‐19 or presentation of clinical symptoms (fatigue with either fever (> 37.2ºC) and/or a persistent cough); time frame: 21 days following randomisation Secondary outcomes: Proportion of participants requiring hospitalisation for COVID‐19/flu‐like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrolment; time frame: 21 days following randomisation Tolerability of nitric oxide releasing solution (NORS) treatment; time frame: 21 days following randomisation
Starting date	8 May 2020
Contact information	Chris Miller Email: chris@sanotize.com
Notes	Primarily a prevention study, but has a second arm to the trial that considers the use of the same interventions in individuals who have COVID‐19 (relevant for another review in this suite).  Trial registered in the USA Estimated completion date: September 2020